An interventional study of Faros Sensor (FS) and LifeInsight Hub and Fast Fix electrode patch in Amyotrophic Lateral Sclerosis, sponsored by GlaxoSmithKline. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-12-26.
Sponsored by GlaxoSmithKline · Not applicable, Interventional, and Other
Study 201283 is an exploratory, non-controlled, non-drug study in Amyotrophic Lateral Sclerosis (ALS) subjects. This study is being conducted as the first step for developing new meaningful measure(s) which might prove to be more effective than existing measures for monitoring clinical function and disease course in ALS. The objective of this study is to test novel measures of movement/physical activity, heart rate and speech and explore how they measure disease progression by evaluating their relationship to gold standard measures of function. This study will be conducted in two phases. A variable length Pilot Phase to test biotelemetry instruments and algorithms reliability and ease of use/acceptance. Approximately 5 subjects will have at least 1 clinic visit to perform a series of set reference tasks while wearing the accelerometer and electrode. Subjects will also continuously wear the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (i.e., home monitoring). Subjects in the Pilot Phase will continue in the study and participate in the Core Study Phase. A 48 week Core Study Phase will be conducted to evaluate how measures of movement/physical activity, speech and Heart Rate Variability (HRV) relate to ALS disease progression. During this phase, a maximum of 25 subjects will be enrolled. Subjects will attend 5 clinic visits to perform gold standard measures of function and perform a series of set reference tasks while wearing the accelerometer and electrode. In between clinic visits, every month subjects will attach the accelerometer and electrode and wear it for approximately 3 days in their home. A telephone contact with the subject will be made by the site at the end of each 3-day home monitoring period.
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Exclusion Criteria:
During Pilot phase,subjects will attend clinic at least once to perform a series of set reference tasks while wearing the accelerometer and electrode. Subjects will also continuously wear the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visit (home monitoring). During 48 week Core Study, subjects will attend 5 clinic visits to perform gold standard measures of function (ALS Functional Rating Scale-Revised and Forced Vital Capacity) and perform a series of set reference tasks while wearing the accelerometer and electrode. Subjects will also continuously wear the accelerometer and electrode in their routine home-life setting for approximately 3 days after the clinic visits (home monitoring). In between clinic visits, subjects will attach the accelerometer and electrode and wear it for approximately 3 days in their home. A telephone contact with the subject will be made by the site at the end of each 3-day home monitoring period
Device: Faros Sensor (FS) and LifeInsight Hub · Device: Fast Fix electrode patch · Procedure: Quantitative Measure of Speech (Core Phase Only)
Each subject will be issued one FS and a MAT LifeInsight Hub for use during the study. At each clinic visit in the Pilot and Core Study Phases, the Faros sensor will be placed on the subject just prior to the defined reference tasks and will be worn on the subject's sternum during completion of the tasks. The morning after the clinic visit, the subject will re-attach the sensor and wear it for approximately 3 days. In between visits during the Core Study Phase the subject will wear the FS every month for approximately 3 days to enable data collection on a monthly basis over the 48 week study period. Movement/physical activity data will be collected by the FS throughout the study.
The Fast Fix electrode patch will be worn with the FS on the subject's sternum according to the same schedule as the FS. The Fast Fix electrode patch will be replaced by the subject on a daily basis during the 3 day monitoring period. Subjects will be provided instructions on how to operate and wear the Fast Fix electrode patch.
Subjects will follow simple prompts on a computer screen instructing them to say a series of vowels, words, and paragraphs which will be recorded using a high definition digital microphone and stored securely on a laptop. The speech waveform data will be sent via secure method to GSK/MAT for processing.
Duration of Day Time Wear Time of the Device
Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of day time wear time was calculated by adding the durations of the time spent \[Active + lying + sedentary not lying\] in the day time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).NA indicates that data could not be calculated as participant number was \<=1.
Time frame: Up to Week 48
Duration of Night Time Wear Time of the Device
Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of night time wear time was the calculated as the total of the times spent \[Active + day time lying + day time "sedentary not lying"\] for the night time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1.
Time frame: Up to Week 48
Average Time Spent Active
Number of minutes spent active per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
Time frame: Up to Week 48
Average Time Spent 'Sedentary Not Lying'
Number of minutes spent 'sedentary not lying' per day and night for 24-hour recording period; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Average Time Spent Lying
Number of minutes spent lying per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Average Time Spent Sedentary.
Number of minutes spent sedentary \[time spent lying + time spent sedentary not lying\] per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Time Spent With Sensor Off
Sensor off time includes the time that the sensor was either switched off or the participant was not wearing it (or both). This outcome measure was planned but not performed.
Time frame: Up to Week 48
Total Activity Count
Total activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Maximum Activity Count in a 24 Hour Period
Maximum activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
Time frame: Up to Week 48
Mean Maximum Activity Count in a 24 Hour Period
Mean maximum activity count of day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
Time frame: Up to Week 48
Number of Continuous Active Periods
Active periods were catagorized as \>1minute to \<=2minutes, \>2 minutes to \<=5minutes, \>5 minutes to \<=15 minutes, \>15 minutes to \<=30 minutes, \>30 minutes. Total number of 'active periods were calculated as 1minute\<x\<2minutes + 'number of active periods 2minutes\<x\<5minutes + 'number of active periods 5minutes\<x\<15minutes + 'number of active periods 15minutes\<x\<30minutes + 'number of active periods \>30minutes.
Time frame: Up to Week 48
Percent of Time Lying Down at Night
Percent time spent lying per day and night over the 24-hour recording periods; averaged for each timepoint
Time frame: Up to Week 48
Number of Night Time Movement Episodes Per Hour
Average number of night movement episodes per hour for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Percent Time Night-time Rest Efficiency
Average night-time rest efficiency for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
Time frame: Up to Week 48
Rest Fragmentation Index
Rest Fragmentation Index was computed as movement time (%) divided by number of movement episodes for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Average Duration of Night Time Movement Episodes
Average duration of movement episodes for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Relationship Between Average Number Night Time Movements/Hour Versus Total ALSFRS-R
Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented
Time frame: Up to Week 48
Relationship Between Average Duration Movement Episodes at Night Versus Total ALSFRS-R
Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented
Time frame: Up to Week 48
Relationship Between Average Percent Time Night Time Rest Efficiency Versus Total ALSFRS-R
Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented
Time frame: Up to Week 48
Relationship Between Average Night Time Rest Fragmentation Index Versus Total ALSFRS-R
Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented
Time frame: Up to Week 48
Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF])
Mean Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Variance of HRV While Lying (LF/HF)
Variance of Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Mean HRV While Sedentary Not Lying (LF/HF)
Mean Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Variance of HRV While Sedentary Not Lying (LF/HF)
Variance of Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Mean HRV While Active (LF/HF)
Mean Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data is not available. Standard deviation could not be calculated when number of participants was \<=1
Time frame: Up to Week 48
Variance of HRV While Active (LF/HF)
Variance of Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1
Time frame: Up to Week 48
Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis)
The effect of being upright on mean HRV was calculated as \[mean HRV while sedentary not lying minus mean HRV while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Effect of Being Upright on HRV Variance (LF/HF Analysis)
The effect of being upright on HRV variance was calculated as \[HRV variance while sedentary not lying minus HRV variance while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Effect of Activity on Mean HRV (LF/HF)
The effect of activity on mean HRV was calculated as \[mean HRV while sedentary not lying minus mean HRV while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1.
Time frame: Up to Week 48
Effect of Activity on HRV Variance (LF/HF Analysis)
The effect of activity on HRV variance was calculated as \[HRV variance while sedentary not lying minus HRV variance while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1.
Time frame: Up to Week 48
Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD)
Mean HRV over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis
HRV variance over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R
Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that sample size was insufficient to calculate correlation coefficient
Time frame: Up to Week 48
Measurement of Speech Quality
Speech quality was assessed by Central Tendency of Fundamental Frequency (CTF) F0, jitter, and shimmer for 'short ah' and 'long ah' tests. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Duration of Maximum Gap Between Words
Duration of maximum gap between words during running speech to planned to analyze quality of speech however; was not performed.
Time frame: Up to Week 48
Speaking Rate
Speaking rate was analyzed during running speech. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Average Phoneme Rate
Phoneme rate was analyzed for the single word "doily". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Maximum Phonation Time
Maximum phonation time for the single word "doily" test was analyzed for quality of speech testing. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Seconds
Percentage Pause Time
Percentage pause time for running speech was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Relationship Between Absolute Values of Speech Endpoints and Absolute Value of ALSFRS-R
Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Repeated Measures Correlation Coefficient has been presented in the table below
Time frame: Up to Week 48
Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC
Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Between Subject Correlation Coefficient has been presented in the table below
Time frame: Up to Week 48
Number of Participants Reporting Sensor Comfort
Participant's feedback on whether the sensor was comfortable to wear was categorized as "yes" and "no". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Number of Participants Reporting Impact on Sleep
Participant feedback on how much the sensor impacted their sleep was categorized as "not at all", "moderately" and "minimally". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Number of Participants With Ease of Setting up and Attaching the Sensor
The participants were required to give feedback on how easy was it to set up and/ or attach the sensor and it was categorized as "easy", "neutral" and "difficult". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Number of Participants With Corresponding Activity Level Required to Complete Their Job
The activity level required by the participant to complete their job was recorded, and was categorized as Not working, Physical activity required, and Sedentary. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor
Average activity level during the time of wearing the sensor was reported by the participants, and was categorized as very low level activity, low level activity, moderate level activity and high level activity. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Number of Participants Whose Sensor Fell Off
The participants reported whether the sensor fell off. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Up to Week 48
Number of Participants With Adverse Events Secondary to the Devices Used or Due to Study Procedures
Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE.
Time frame: Up to Week 48
Type of Adverse Events Secondary to the Devices Used or Due to Study Procedures
Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Number of AEs, SAEs and Adverse events leading to discontinuation (AELDs)from the study is presented
Time frame: Up to Week 48
This is an exploratory, non-controlled, non-drug study in participants with amyotrophic lateral sclerosis (ALS). The study enrolled participants using two sites based in the United Kingdom
| Milestone | Mega Faros Device + Fast Fix |
|---|---|
| Started | 25 |
| Completed | 18 |
| Not completed | 7 |
| Withdrew: Adverse event | 2 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 4 |
Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of day time wear time was calculated by adding the durations of the time spent \[Active + lying + sedentary not lying\] in the day time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).NA indicates that data could not be calculated as participant number was \<=1.
| Minutes | Mega Faros Device + Fast Fix |
|---|---|
| Week 0, Day 1, n=24 | 718.536 ± 190.4933 |
| Week 0, Day 2, n=24 | 730.882 ± 216.3616 |
| Week 0, Day 3, n=23 | 653.980 ± 241.0427 |
| Week 0, Day 4, n=12 | 207.263 ± 275.7507 |
| Week 0, Day 5, n=2 | 342.830 ± 240.4163 |
| Week4, Day 1, n=22 | 762.680 ± 228.5267 |
| Week4, Day 2, n=22 | 778.636 ± 169.6978 |
| Week4, Day 3, n=21 | 605.334 ± 319.5373 |
| Week4, Day 4, n=9 | 207.092 ± 293.8405 |
| Week4, Day 5, n=5 | 137.600 ± 300.5371 |
| Week4, Day 6, n=1 | 657.500 ± NA |
| Week4, Day 7, n=1 | 820.660 ± NA |
| Week4, Day 8, n=1 | 34.000 ± NA |
| Week8, Day 1, n=19 | 647.735 ± 291.5468 |
| Week8, Day 2, n=17 | 744.028 ± 158.3890 |
| Week8, Day 3, n=17 | 581.939 ± 297.5053 |
| Week8, Day 4, n=8 | 94.709 ± 126.7088 |
| Week12,Day 1, n=16 | 552.668 ± 315.5227 |
| Week12,Day 2, n=16 | 801.697 ± 170.8600 |
| Week12,Day 3, n=15 | 563.311 ± 298.3566 |
| Week12,Day 4, n=7 | 425.336 ± 266.8420 |
| Week12,Day 5, n=1 | 858.660 ± NA |
| Week16,Day 1, n=13 | 759.399 ± 129.2502 |
| Week16,Day 2, n=13 | 812.345 ± 200.5683 |
| Week16,Day 3, n=12 | 631.484 ± 296.3050 |
| Week16,Day 4, n=6 | 254.500 ± 336.6649 |
| Week20,Day 1, n=14 | 774.049 ± 240.7234 |
| Week20,Day 2, n=13 | 648.268 ± 291.9654 |
| Week20,Day 3, n=12 | 615.277 ± 239.5376 |
| Week20,Day 4, n=4 | 172.793 ± 345.3584 |
| Week24,Day 1, n=14 | 505.976 ± 296.3016 |
| Week24,Day 2, n=12 | 617.599 ± 299.5749 |
| Week24,Day 3, n=11 | 481.698 ± 333.5209 |
| Week24,Day 4, n=8 | 306.500 ± 303.9026 |
| Week24,Day 5, n=2 | 287.000 ± 184.7953 |
| Week28,Day 1, n=10 | 690.898 ± 178.9577 |
| Week28,Day 2, n=10 | 722.551 ± 248.5576 |
| Week28,Day 3, n=9 | 588.464 ± 359.3972 |
| Week28,Day 4, n=6 | 357.220 ± 363.2050 |
| Week32,Day 1, n=12 | 575.303 ± 322.1123 |
| Week32,Day 2, n=10 | 592.866 ± 345.4597 |
| Week32,Day 3, n=9 | 599.778 ± 351.8631 |
| Week32,Day 4, n=1 | 32.000 ± NA |
| Week36,Day 1, n=12 | 510.209 ± 381.7060 |
| Week36,Day 2, n=9 | 507.872 ± 397.7501 |
| Week36,Day 3, n=6 | 465.583 ± 340.8965 |
| Week36,Day 4, n=4 | 387.750 ± 424.1863 |
| Week36,Day 5, n=2 | 516.250 ± 454.3161 |
| Week36,Day 6, n=1 | 171.840 ± NA |
| Week40,Day 1, n=12 | 722.708 ± 239.1189 |
| Week40,Day 2, n=12 | 618.555 ± 326.7927 |
| Week40,Day 3, n=11 | 601.665 ± 312.9329 |
| Week40,Day 4, n=7 | 290.857 ± 404.5156 |
| Week40,Day 5, n=1 | 823.500 ± NA |
| Week40,Day 6, n=1 | 444.830 ± NA |
| Week44,Day 1, n=12 | 746.278 ± 258.7132 |
| Week44,Day 2, n=11 | 646.452 ± 295.5684 |
| Week44,Day 3, n=10 | 476.783 ± 355.1196 |
| Week44,Day 4, n=4 | 178.460 ± 308.3123 |
| Week44,Day 5, n=1 | 146.660 ± NA |
| Week48,Day 1, n=13 | 779.438 ± 120.7527 |
| Week48,Day 2, n=13 | 692.474 ± 251.7305 |
| Week48,Day 3, n=10 | 622.015 ± 243.5040 |
| Week48,Day 4, n=5 | 630.000 ± 380.2256 |
Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of night time wear time was the calculated as the total of the times spent \[Active + day time lying + day time "sedentary not lying"\] for the night time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1.
| Minutes | Mega Faros Device + Fast Fix |
|---|---|
| Week 0, Day 1, n=24 | 448.174 ± 222.1658 |
| Week 0, Day 2, n=24 | 360.575 ± 212.4216 |
| Week 0, Day 3, n=23 | 482.500 ± 150.8251 |
| Week 0, Day 4, n=12 | 134.570 ± 239.8401 |
| Week 0, Day 5, n=2 | 494.170 ± 57.9828 |
| Week4, Day 1, n=22 | 487.682 ± 189.6054 |
| Week4, Day 2, n=22 | 432.273 ± 209.9463 |
| Week4, Day 3, n=21 | 455.047 ± 194.3802 |
| Week4, Day 4, n=9 | 107.796 ± 205.8403 |
| Week4, Day 5, n=5 | 109.400 ± 241.1904 |
| Week4, Day 6, n=1 | 624.500 ± NA |
| Week4, Day 7, n=1 | 462.340 ± NA |
| Week4, Day 8, n=1 | 0.000 ± NA |
| Week8, Day 1, n=19 | 506.316 ± 184.6635 |
| Week8, Day 2, n=17 | 477.441 ± 206.7924 |
| Week8, Day 3, n=17 | 526.825 ± 207.6252 |
| Week8, Day 4, n=8 | 30.041 ± 84.9695 |
| Week12,Day 1, n=16 | 255.708 ± 250.9718 |
| Week12,Day 2, n=16 | 418.489 ± 149.6411 |
| Week12,Day 3, n=15 | 519.888 ± 63.0517 |
| Week12,Day 4, n=7 | 568.381 ± 150.2560 |
| Week12,Day 5, n=1 | 406.340 ± NA |
| Week16,Day 1, n=13 | 513.448 ± 78.9644 |
| Week16,Day 2, n=13 | 382.038 ± 185.6318 |
| Week16,Day 3, n=12 | 494.932 ± 196.5556 |
| Week16,Day 4, n=6 | 96.000 ± 220.5519 |
| Week20,Day 1, n=14 | 445.811 ± 170.4490 |
| Week20,Day 2, n=13 | 452.345 ± 203.3159 |
| Week20,Day 3, n=12 | 498.806 ± 138.8339 |
| Week20,Day 4, n=4 | 148.458 ± 172.2844 |
| Week24,Day 1, n=14 | 254.095 ± 261.1246 |
| Week24,Day 2, n=12 | 398.068 ± 199.7096 |
| Week24,Day 3, n=11 | 374.121 ± 214.6214 |
| Week24,Day 4, n=8 | 291.376 ± 277.4058 |
| Week24,Day 5, n=2 | 476.995 ± 1.8880 |
| Week28,Day 1, n=10 | 497.701 ± 242.6652 |
| Week28,Day 2, n=10 | 483.950 ± 195.5384 |
| Week28,Day 3, n=9 | 543.759 ± 270.4945 |
| Week28,Day 4, n=6 | 286.778 ± 327.2635 |
| Week32,Day 1, n=12 | 510.447 ± 218.5192 |
| Week32,Day 2, n=10 | 460.233 ± 209.0824 |
| Week32,Day 3, n=9 | 433.778 ± 256.9437 |
| Week32,Day 4, n=1 | 0.000 ± NA |
| Week36,Day 1, n=12 | 189.124 ± 199.2290 |
| Week36,Day 2, n=9 | 263.352 ± 236.3438 |
| Week36,Day 3, n=6 | 380.748 ± 298.7767 |
| Week36,Day 4, n=4 | 358.503 ± 280.5689 |
| Week36,Day 5, n=2 | 201.250 ± 284.6105 |
| Week36,Day 6, n=1 | 505.170 ± NA |
| Week40,Day 1, n=12 | 375.043 ± 192.0867 |
| Week40,Day 2, n=12 | 442.528 ± 179.2818 |
| Week40,Day 3, n=11 | 419.334 ± 215.0470 |
| Week40,Day 4, n=7 | 121.573 ± 172.7203 |
| Week40,Day 5, n=1 | 522.500 ± NA |
| Week40,Day 6, n=1 | 163.170 ± NA |
| Week44,Day 1, n=12 | 393.140 ± 192.6969 |
| Week44,Day 2, n=11 | 362.275 ± 208.9128 |
| Week44,Day 3, n=10 | 382.018 ± 201.1957 |
| Week44,Day 4, n=4 | 111.543 ± 223.0850 |
| Week44,Day 5, n=1 | 277.330 ± NA |
| Week48,Day 1, n=13 | 439.486 ± 153.3470 |
| Week48,Day 2, n=13 | 381.988 ± 192.9540 |
| Week48,Day 3, n=10 | 299.985 ± 146.9104 |
| Week48,Day 4, n=5 | 81.400 ± 182.0159 |
Number of minutes spent active per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Minutes | Mega Faros Device + Fast Fix |
|---|---|
| Day time, Week 0, n=24 | 34.420 ± 29.3837 |
| Day time, Week 4, n=22 | 32.233 ± 33.1012 |
| Day time, Week 8, n=19 | 24.319 ± 25.5092 |
| Day time, Week 12, n=16 | 23.904 ± 17.2952 |
| Day time, Week 16, n=13 | 25.863 ± 23.2673 |
| Day time, Week 20, n=14 | 18.931 ± 18.3595 |
| Day time, Week 24, n=14 | 12.137 ± 10.8409 |
| Day time, Week 28, n=10 | 19.856 ± 29.0562 |
| Day time, Week 32, n=12 | 11.873 ± 15.0988 |
| Day time, Week 36, n=12 | 14.118 ± 19.7452 |
| Day time, Week 40, n=12 | 14.563 ± 18.7912 |
| Day time, Week 44, n=12 | 20.210 ± 26.0361 |
| Day time, Week 48, n=13 | 23.578 ± 29.0419 |
| Night time, Week 0, n=24 | 1.136 ± 1.5427 |
| Night time, Week 4, n=22 | 0.570 ± 0.6817 |
| Night time, Week 8, n=19 | 2.375 ± 5.7540 |
| Night time, Week 12, n=16 | 0.484 ± 0.5404 |
| Night time, Week 16, n=13 | 0.449 ± 0.4684 |
| Night time, Week 20, n=14 | 0.418 ± 0.5315 |
| Night time, Week 24, n=14 | 0.387 ± 0.2715 |
| Night time, Week 28, n=10 | 1.432 ± 3.0455 |
| Night time, Week 32, n=12 | 0.668 ± 1.5814 |
| Night time, Week 36, n=12 | 0.414 ± 0.3682 |
| Night time, Week 40, n=12 | 0.268 ± 0.3272 |
| Night time, Week 44, n=12 | 0.390 ± 0.7308 |
| Night time, Week 48, n=13 | 0.518 ± 0.8014 |
Number of minutes spent 'sedentary not lying' per day and night for 24-hour recording period; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Minutes | Mega Faros Device + Fast Fix |
|---|---|
| Day time, Week 0, n=24 | 523.191 ± 113.3016 |
| Day time, Week 4, n=22 | 524.120 ± 182.7753 |
| Day time, Week 8, n=19 | 428.359 ± 210.1894 |
| Day time, Week 12, n=16 | 509.634 ± 105.3263 |
| Day time, Week 16, n=13 | 561.923 ± 100.3003 |
| Day time, Week 20, n=14 | 489.921 ± 202.2926 |
| Day time, Week 24, n=14 | 376.117 ± 222.6009 |
| Day time, Week 28, n=10 | 472.238 ± 215.7768 |
| Day time, Week 32, n=12 | 420.709 ± 259.0856 |
| Day time, Week 36, n=12 | 376.686 ± 233.1990 |
| Day time, Week 40, n=12 | 465.879 ± 181.5005 |
| Day time, Week 44, n=12 | 440.376 ± 198.2569 |
| Day time, Week 48, n=13 | 509.536 ± 171.1560 |
| Night time, Week 0, n=24 | 15.522 ± 28.5337 |
| Night time, Week 4, n=22 | 10.561 ± 12.5485 |
| Night time, Week 8, n=19 | 8.441 ± 5.8601 |
| Night time, Week 12, n=16 | 7.968 ± 4.8657 |
| Night time, Week 16, n=13 | 8.855 ± 5.1855 |
| Night time, Week 20, n=14 | 9.239 ± 6.9942 |
| Night time, Week 24, n=14 | 7.274 ± 6.5610 |
| Night time, Week 28, n=10 | 17.488 ± 15.1698 |
| Night time, Week 32, n=12 | 12.930 ± 14.8779 |
| Night time, Week 36, n=12 | 3.545 ± 3.5805 |
| Night time, Week 40, n=12 | 8.932 ± 5.0236 |
| Night time, Week 44, n=12 | 6.321 ± 4.5166 |
| Night time, Week 48, n=13 | 7.602 ± 7.4373 |
Number of minutes spent lying per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Minutes | Mega Faros Device + Fast Fix |
|---|---|
| Day time, Week 0, n=24 | 79.027 ± 59.8512 |
| Day time, Week 4, n=22 | 79.996 ± 67.1924 |
| Day time, Week 8, n=19 | 90.324 ± 80.8799 |
| Day time, Week 12, n=16 | 82.146 ± 59.7457 |
| Day time, Week 16, n=13 | 87.271 ± 75.4731 |
| Day time, Week 20, n=14 | 89.648 ± 90.8020 |
| Day time, Week 24, n=14 | 82.979 ± 89.4852 |
| Day time, Week 28, n=10 | 136.170 ± 127.2225 |
| Day time, Week 32, n=12 | 99.760 ± 118.3536 |
| Day time, Week 36, n=12 | 50.278 ± 48.7456 |
| Day time, Week 40, n=12 | 103.749 ± 133.3234 |
| Day time, Week 44, n=12 | 71.757 ± 73.5817 |
| Day time, Week 48, n=13 | 141.575 ± 140.1450 |
| Night time, Week 0, n=24 | 384.886 ± 135.8136 |
| Night time, Week 4, n=22 | 384.879 ± 97.8424 |
| Night time, Week 8, n=19 | 411.110 ± 157.8820 |
| Night time, Week 12, n=16 | 417.943 ± 71.9066 |
| Night time, Week 16, n=13 | 413.721 ± 129.3161 |
| Night time, Week 20, n=14 | 407.060 ± 175.2092 |
| Night time, Week 24, n=14 | 318.155 ± 112.8749 |
| Night time, Week 28, n=10 | 454.137 ± 184.2617 |
| Night time, Week 32, n=12 | 412.196 ± 170.4452 |
| Night time, Week 36, n=12 | 217.884 ± 181.3682 |
| Night time, Week 40, n=12 | 355.222 ± 104.8680 |
| Night time, Week 44, n=12 | 319.022 ± 155.2519 |
| Night time, Week 48, n=13 | 333.358 ± 154.9236 |
Number of minutes spent sedentary \[time spent lying + time spent sedentary not lying\] per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Minutes | Mega Faros Device + Fast Fix |
|---|---|
| Day time, Week 0, n=24 | 602.219 ± 131.7430 |
| Day time, Week 4, n=22 | 604.116 ± 165.0799 |
| Day time, Week 8, n=19 | 518.684 ± 234.6306 |
| Day time, Week 12, n=16 | 591.779 ± 118.3797 |
| Day time, Week 16, n=13 | 649.195 ± 117.2721 |
| Day time, Week 20, n=14 | 579.571 ± 213.9093 |
| Day time, Week 24, n=14 | 459.096 ± 233.1413 |
| Day time, Week 28, n=10 | 608.409 ± 141.5444 |
| Day time, Week 32, n=12 | 520.468 ± 285.7109 |
| Day time, Week 36, n=12 | 426.962 ± 250.2390 |
| Day time, Week 40, n=12 | 569.629 ± 171.5586 |
| Day time, Week 44, n=12 | 512.132 ± 203.0705 |
| Day time, Week 48, n=13 | 651.109 ± 156.3296 |
| Night time, Week 0, n=24 | 400.408 ± 132.3420 |
| Night time, Week 4, n=22 | 395.438 ± 100.9179 |
| Night time, Week 8, n=19 | 419.549 ± 162.0795 |
| Night time, Week 12, n=16 | 425.909 ± 69.7741 |
| Night time, Week 16, n=13 | 422.574 ± 132.3307 |
| Night time, Week 20, n=14 | 416.299 ± 179.9825 |
| Night time, Week 24, n=14 | 325.427 ± 114.9446 |
| Night time, Week 28, n=10 | 471.626 ± 196.1417 |
| Night time, Week 32, n=12 | 425.125 ± 178.8053 |
| Night time, Week 36, n=12 | 221.430 ± 184.4017 |
| Night time, Week 40, n=12 | 364.152 ± 105.2901 |
| Night time, Week 44, n=12 | 325.343 ± 156.8669 |
| Night time, Week 48, n=13 | 340.960 ± 157.6860 |
Sensor off time includes the time that the sensor was either switched off or the participant was not wearing it (or both). This outcome measure was planned but not performed.
No measurements were reported for this outcome.
Total activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Count of activity | Mega Faros Device + Fast Fix |
|---|---|
| Day time, Week 0, n=24 | 3336.550 ± 2654.406 |
| Day time, Week 4, n=22 | 2903.633 ± 3059.200 |
| Day time, Week 8, n=17 | 4244.521 ± 6314.828 |
| Day time, Week 12, n=16 | 2076.129 ± 1338.276 |
| Day time, Week 16, n=13 | 2216.162 ± 1732.185 |
| Day time, Week 20, n=14 | 1858.116 ± 1504.067 |
| Day time, Week 24, n=13 | 1114.152 ± 683.2223 |
| Day time, Week 28, n=10 | 1468.741 ± 1559.431 |
| Day time, Week 32, n=12 | 1247.969 ± 1015.319 |
| Day time, Week 36, n=12 | 1675.754 ± 1979.210 |
| Day time, Week 40, n=12 | 1542.138 ± 1421.696 |
| Day time, Week 44, n=12 | 2252.325 ± 1923.793 |
| Day time, Week 48, n=13 | 1972.506 ± 2209.802 |
| Night time, Week 0, n=24 | 357.865 ± 293.7938 |
| Night time, Week 4, n=22 | 265.096 ± 102.7897 |
| Night time, Week 8, n=13 | 652.108 ± 1445.624 |
| Night time, Week 12, n=16 | 234.854 ± 68.8019 |
| Night time, Week 16, n=13 | 254.238 ± 46.4883 |
| Night time, Week 20, n=14 | 241.504 ± 68.9048 |
| Night time, Week 24, n=14 | 249.504 ± 165.5673 |
| Night time, Week 28, n=10 | 328.374 ± 222.3131 |
| Night time, Week 32, n=12 | 271.988 ± 189.5221 |
| Night time, Week 36, n=10 | 211.270 ± 101.4570 |
| Night time, Week 40, n=12 | 212.134 ± 68.5433 |
| Night time, Week 44, n=11 | 232.571 ± 117.1910 |
| Night time, Week 48, n=13 | 224.375 ± 110.9312 |
Maximum activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Count of activity | Mega Faros Device + Fast Fix |
|---|---|
| Day time, Week 0, n=24 | 2803.906 ± 2819.342 |
| Day time, Week 4, n=22 | 1915.344 ± 1787.325 |
| Day time, Week 8, n=17 | 3520.196 ± 6145.555 |
| Day time, Week 12, n=16 | 2004.569 ± 1341.035 |
| Day time, Week 16, n=13 | 2337.092 ± 2537.966 |
| Day time, Week 20, n=14 | 1923.578 ± 1690.000 |
| Day time, Week 24, n=13 | 1050.409 ± 831.3745 |
| Day time, Week 28, n=10 | 960.596 ± 667.9179 |
| Day time, Week 32, n=12 | 815.954 ± 772.5387 |
| Day time, Week 36, n=12 | 1238.367 ± 1121.657 |
| Day time, Week 40, n=12 | 897.363 ± 785.0252 |
| Day time, Week 44, n=12 | 1940.100 ± 2346.428 |
| Day time, Week 48, n=13 | 1647.037 ± 1645.568 |
| Night time, Week 0, n=24 | 657.385 ± 823.5054 |
| Night time, Week 4, n=22 | 511.867 ± 599.0219 |
| Night time, Week 8, n=19 | 676.360 ± 1168.379 |
| Night time, Week 12, n=16 | 280.178 ± 222.3819 |
| Night time, Week 16, n=13 | 440.992 ± 641.4221 |
| Night time, Week 20, n=13 | 306.540 ± 293.6219 |
| Night time, Week 24, n=14 | 442.779 ± 611.4870 |
| Night time, Week 28, n=10 | 708.219 ± 967.2115 |
| Night time, Week 32, n=12 | 479.673 ± 590.4367 |
| Night time, Week 36, n=10 | 462.395 ± 313.6826 |
| Night time, Week 40, n=12 | 278.703 ± 264.5554 |
| Night time, Week 44, n=11 | 383.820 ± 273.3449 |
| Night time, Week 48, n=13 | 493.870 ± 524.4698 |
Mean maximum activity count of day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Count of activity | Mega Faros Device + Fast Fix |
|---|---|
| Day time, Week 0, n=24 | 1618.403 ± 1288.502 |
| Day time, Week 4, n=22 | 1309.195 ± 1042.150 |
| Day time, Week 8, n=17 | 1612.785 ± 1822.405 |
| Day time, Week 12, n=16 | 1165.166 ± 705.7684 |
| Day time, Week 16, n=13 | 1510.868 ± 1407.533 |
| Day time, Week 20, n=14 | 1146.578 ± 1016.899 |
| Day time, Week 24, n=13 | 697.693 ± 678.2212 |
| Day time, Week 28, n=10 | 665.987 ± 475.5967 |
| Day time, Week 32, n=12 | 633.595 ± 536.0698 |
| Day time, Week 36, n=12 | 772.909 ± 672.3572 |
| Day time, Week 40, n=12 | 543.052 ± 410.3246 |
| Day time, Week 44, n=12 | 1074.333 ± 988.7887 |
| Day time, Week 48, n=13 | 1002.060 ± 1011.468 |
| Night time, Week 0, n=24 | 319.872 ± 312.3125 |
| Night time, Week 4, n=22 | 231.630 ± 183.2420 |
| Night time, Week 8, n=19 | 518.646 ± 1153.825 |
| Night time, Week 12, n=16 | 176.211 ± 142.6990 |
| Night time, Week 16, n=13 | 194.670 ± 208.1798 |
| Night time, Week 20, n=13 | 174.990 ± 153.0679 |
| Night time, Week 24, n=14 | 208.871 ± 184.5488 |
| Night time, Week 28, n=10 | 325.419 ± 356.4562 |
| Night time, Week 32, n=12 | 267.311 ± 294.0265 |
| Night time, Week 36, n=10 | 242.772 ± 159.5699 |
| Night time, Week 40, n=12 | 145.523 ± 109.5598 |
| Night time, Week 44, n=11 | 207.506 ± 134.7506 |
| Night time, Week 48, n=13 | 233.548 ± 215.7070 |
Active periods were catagorized as \>1minute to \<=2minutes, \>2 minutes to \<=5minutes, \>5 minutes to \<=15 minutes, \>15 minutes to \<=30 minutes, \>30 minutes. Total number of 'active periods were calculated as 1minute\<x\<2minutes + 'number of active periods 2minutes\<x\<5minutes + 'number of active periods 5minutes\<x\<15minutes + 'number of active periods 15minutes\<x\<30minutes + 'number of active periods \>30minutes.
| Number/Hour | Mega Faros Device + Fast Fix |
|---|---|
| >1 to <=2minutes; Day time, Week 0, n=24 | 0.279 ± 0.3174 |
| >1 to <=2minutes;Day time, Week 4, n=22 | 0.267 ± 0.3874 |
| >1 to <=2minutes;Day time, Week 8, n=18 | 0.255 ± 0.3230 |
| >1 to <=2minutes;Day time, Week 12, n=16 | 0.188 ± 0.1925 |
| >1 to <=2minutes;Day time, Week 16, n=13 | 0.191 ± 0.1996 |
| >1 to <=2minutes;Day time, Week 20, n=14 | 0.169 ± 0.1812 |
| >1 to <=2minutes;Day time, Week 24, n=14 | 0.206 ± 0.2088 |
| >1 to <=2minutes;Day time, Week 28, n=10 | 0.147 ± 0.1564 |
| >1 to <=2minutes;Day time, Week 32, n=12 | 0.100 ± 0.1172 |
| >1 to <=2minutes;Day time, Week 36, n=12 | 0.164 ± 0.2649 |
| >1 to <=2minutes;Day time, Week 40, n=12 | 0.170 ± 0.2644 |
| >1 to <=2minutes;Day time, Week 44, n=12 | 0.174 ± 0.2518 |
| >1 to <=2minutes;Day time, Week 48, n=13 | 0.252 ± 0.3609 |
| >2 to <=5minutes; Day time, Week 0, n=24 | 0.108 ± 0.1263 |
| >2 to <=5minutes;Day time, Week 4, n=22 | 0.097 ± 0.1264 |
| >2 to <=5minutes;Day time, Week 8, n=18 | 0.084 ± 0.1675 |
| >2 to <=5minutes;Day time, Week 12, n=16 | 0.108 ± 0.1201 |
| >2 to <=5minutes;Day time, Week 16, n=13 | 0.123 ± 0.1590 |
| >2 to <=5minutes;Day time, Week 20, n=14 | 0.080 ± 0.1105 |
| >2 to <=5minutes;Day time, Week 24, n=14 | 0.057 ± 0.0819 |
| >2 to <=5minutes;Day time, Week 28, n=10 | 0.107 ± 0.1700 |
| >2 to <=5minutes;Day time, Week 32, n=12 | 0.058 ± 0.1129 |
| >2 to <=5minutes;Day time, Week 36, n=12 | 0.079 ± 0.1538 |
| >2 to <=5minutes;Day time, Week 40, n=12 | 0.072 ± 0.1137 |
| >2 to <=5minutes;Day time, Week 44, n=12 | 0.071 ± 0.1417 |
| >2 to <=5minutes;Day time, Week 48, n=13 | 0.095 ± 0.1400 |
| >5 to <=15 minutes; Day time, Week 0, n=24 | 0.041 ± 0.0740 |
| >5 to <=15 minutes;Day time, Week 4, n=22 | 0.030 ± 0.0471 |
| >5 to <=15 minutes;Day time, Week 8, n=18 | 0.020 ± 0.0333 |
| >5 to <=15 minutes;Day time, Week 12, n=16 | 0.023 ± 0.0364 |
| >5 to <=15 minutes;Day time, Week 16, n=13 | 0.042 ± 0.0699 |
| >5 to <=15 minutes;Day time, Week 20, n=14 | 0.016 ± 0.0440 |
| >5 to <=15 minutes;Day time, Week 24, n=14 | 0.000 ± 0.000 |
| >5 to <=15 minutes;Day time, Week 28, n=10 | 0.024 ± 0.0534 |
| >5 to <=15 minutes;Day time, Week 32, n=12 | 0.015 ± 0.0353 |
| >5 to <=15 minutes;Day time, Week 36, n=12 | 0.008 ± 0.0289 |
| >5 to <=15 minutes;Day time, Week 40, n=12 | 0.022 ± 0.0549 |
| >5 to <=15 minutes;Day time, Week 44, n=12 | 0.008 ± 0.0199 |
| >5 to <=15 minutes;Day time, Week 48, n=13 | 0.023 ± 0.0440 |
| >15 to <=30 minutes; Day time, Week 0, n=24 | 0.003 ± 0.0108 |
| >15 to <=30 minutes;Day time, Week 4, n=22 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Day time, Week 8, n=18 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Day time, Week 12, n=16 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Day time, Week 16, n=13 | 0.003 ± 0.0111 |
| >15 to <=30 minutes;Day time, Week 20, n=14 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Day time, Week 24, n=14 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Day time, Week 28, n=10 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Day time, Week 32, n=12 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Day time, Week 36, n=12 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Day time, Week 40, n=12 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Day time, Week 44, n=12 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Day time, Week 48, n=13 | 0.000 ± 0.000 |
| >30 minutes; Day time, Week 0, n=24 | 0.000 ± 0.000 |
| >30 minutes;Day time, Week 4, n=22 | 0.000 ± 0.000 |
| >30 minutes;Day time, Week 8, n=18 | 0.001 ± 0.0047 |
| >30 minutes;Day time, Week 12, n=16 | 0.000 ± 0.000 |
| >30 minutes;Day time, Week 16, n=13 | 0.000 ± 0.000 |
| >30 minutes;Day time, Week 20, n=14 | 0.000 ± 0.000 |
| >30 minutes;Day time, Week 24, n=14 | 0.000 ± 0.000 |
| >30 minutes;Day time, Week 28, n=10 | 0.000 ± 0.000 |
| >30 minutes;Day time, Week 32, n=12 | 0.000 ± 0.000 |
| >30 minutes;Day time, Week 36, n=12 | 0.000 ± 0.000 |
| >30 minutes;Day time, Week 40, n=12 | 0.000 ± 0.000 |
| >30 minutes;Day time, Week 44, n=12 | 0.000 ± 0.000 |
| >30 minutes;Day time, Week 48, n=13 | 0.000 ± 0.000 |
| >1 to <=2minutes; Night time, Week 0, n=24 | 0.015 ± 0.0365 |
| >1 to <=2minutes;Night time, Week 4, n=22 | 0.000 ± 0.000 |
| >1 to <=2minutes;Night time, Week 8, n=19 | 0.046 ± 0.1453 |
| >1 to <=2minutes;Night time, Week 12, n=16 | 0.000 ± 0.000 |
| >1 to <=2minutes;Night time, Week 16, n=13 | 0.000 ± 0.000 |
| >1 to <=2minutes;Night time, Week 20, n=13 | 0.003 ± 0.0111 |
| >1 to <=2minutes;Night time, Week 24, n=14 | 0.000 ± 0.000 |
| >1 to <=2minutes;Night time, Week 28, n=10 | 0.004 ± 0.0126 |
| >1 to <=2minutes;Night time, Week 32, n=12 | 0.004 ± 0.0144 |
| >1 to <=2minutes;Night time, Week 36, n=10 | 0.000 ± 0.000 |
| >1 to <=2minutes;Night time, Week 40, n=12 | 0.000 ± 0.000 |
| >1 to <=2minutes;Night time, Week 44, n=11 | 0.000 ± 0.000 |
| >1 to <=2minutes;Night time, Week 48, n=13 | 0.292 ± 1.0512 |
| >2 to <=5minutes; Night time, Week 0, n=24 | 0.008 ± 0.0284 |
| >2 to <=5minutes;Night time, Week 4, n=22 | 0.000 ± 0.000 |
| >2 to <=5minutes;Night time, Week 8, n=19 | 0.067 ± 0.2617 |
| >2 to <=5minutes;Night time, Week 12, n=16 | 0.000 ± 0.000 |
| >2 to <=5minutes;Night time, Week 16, n=13 | 0.000 ± 0.000 |
| >2 to <=5minutes;Night time, Week 20, n=13 | 0.000 ± 0.000 |
| >2 to <=5minutes;Night time, Week 24, n=14 | 0.000 ± 0.000 |
| >2 to <=5minutes;Night time, Week 28, n=10 | 0.006 ± 0.0190 |
| >2 to <=5minutes;Night time, Week 32, n=12 | 0.000 ± 0.000 |
| >2 to <=5minutes;Night time, Week 36, n=10 | 0.000 ± 0.000 |
| >2 to <=5minutes;Night time, Week 40, n=12 | 0.000 ± 0.000 |
| >2 to <=5minutes;Night time, Week 44, n=11 | 0.000 ± 0.000 |
| >2 to <=5minutes;Night time, Week 48, n=13 | 0.000 ± 0.000 |
| >5 to <=15 minutes; Night time, Week 0, n=24 | 0.000 ± 0.000 |
| >5 to <=15 minutes;Night time, Week 4, n=22 | 0.000 ± 0.000 |
| >5 to <=15 minutes;Night time, Week 8, n=19 | 0.000 ± 0.000 |
| >5 to <=15 minutes;Night time, Week 12, n=16 | 0.000 ± 0.000 |
| >5 to <=15 minutes;Night time, Week 16, n=13 | 0.000 ± 0.000 |
| >5 to <=15 minutes;Night time, Week 20, n=13 | 0.000 ± 0.000 |
| >5 to <=15 minutes;Night time, Week 24, n=14 | 0.000 ± 0.000 |
| >5 to <=15 minutes;Night time, Week 28, n=10 | 0.000 ± 0.000 |
| >5 to <=15 minutes;Night time, Week 32, n=12 | 0.000 ± 0.000 |
| >5 to <=15 minutes;Night time, Week 36, n=10 | 0.000 ± 0.000 |
| >5 to <=15 minutes;Night time, Week 40, n=12 | 0.000 ± 0.000 |
| >5 to <=15 minutes;Night time, Week 44, n=11 | 0.000 ± 0.000 |
| >5 to <=15 minutes;Night time, Week 48, n=13 | 0.000 ± 0.000 |
| >15 to <=30 minutes; Night time, Week 0, n=24 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Night time, Week 4, n=22 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Night time, Week 8, n=19 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Night time, Week 12, n=16 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Night time, Week 16, n=13 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Night time, Week 20, n=13 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Night time, Week 24, n=14 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Night time, Week 28, n=10 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Night time, Week 32, n=12 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Night time, Week 36, n=10 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Night time, Week 40, n=12 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Night time, Week 44, n=11 | 0.000 ± 0.000 |
| >15 to <=30 minutes;Night time, Week 48, n=13 | 0.000 ± 0.000 |
| >30 minutes; Night time, Week 0, n=24 | 0.000 ± 0.000 |
| >30 minutes;Night time, Week 4, n=22 | 0.000 ± 0.000 |
| >30 minutes;Night time, Week 8, n=19 | 0.000 ± 0.000 |
| >30 minutes;Night time, Week 12, n=16 | 0.000 ± 0.000 |
| >30 minutes;Night time, Week 16, n=13 | 0.000 ± 0.000 |
| >30 minutes;Night time, Week 20, n=13 | 0.000 ± 0.000 |
| >30 minutes;Night time, Week 24, n=14 | 0.000 ± 0.000 |
| >30 minutes;Night time, Week 28, n=10 | 0.000 ± 0.000 |
| >30 minutes;Night time, Week 32, n=12 | 0.000 ± 0.000 |
| >30 minutes;Night time, Week 36, n=10 | 0.000 ± 0.000 |
| >30 minutes;Night time, Week 40, n=12 | 0.000 ± 0.000 |
| >30 minutes;Night time, Week 44, n=11 | 0.000 ± 0.000 |
| >30 minutes;Night time, Week 48, n=13 | 0.000 ± 0.000 |
Percent time spent lying per day and night over the 24-hour recording periods; averaged for each timepoint
| Percentage of time | Mega Faros Device + Fast Fix |
|---|---|
| Day time, Week 0, n=24 | 12.079 ± 8.3771 |
| Day time, Week 4, n=22 | 14.119 ± 13.8340 |
| Day time, Week 8, n=18 | 17.993 ± 12.7684 |
| Day time, Week 12, n=16 | 13.101 ± 9.7891 |
| Day time, Week 16, n=13 | 12.400 ± 9.3903 |
| Day time, Week 20, n=14 | 21.198 ± 25.9982 |
| Day time, Week 24, n=14 | 23.608 ± 28.1925 |
| Day time, Week 28, n=10 | 23.603 ± 23.9283 |
| Day time, Week 32, n=12 | 26.613 ± 34.2248 |
| Day time, Week 36, n=12 | 21.823 ± 28.2251 |
| Day time, Week 40, n=12 | 17.453 ± 19.6178 |
| Day time, Week 44, n=12 | 20.397 ± 26.7615 |
| Day time, Week 48, n=13 | 20.966 ± 20.3006 |
| Night time, Week 0, n=24 | 95.131 ± 8.2933 |
| Night time, Week 4, n=22 | 97.280 ± 2.9257 |
| Night time, Week 8, n=19 | 96.871 ± 4.0262 |
| Night time, Week 12, n=16 | 97.886 ± 1.4457 |
| Night time, Week 16, n=13 | 97.817 ± 1.1466 |
| Night time, Week 20, n=13 | 97.739 ± 1.1617 |
| Night time, Week 24, n=14 | 97.522 ± 1.6446 |
| Night time, Week 28, n=10 | 96.397 ± 2.1777 |
| Night time, Week 32, n=12 | 95.519 ± 6.0885 |
| Night time, Week 36, n=10 | 98.165 ± 0.6796 |
| Night time, Week 40, n=12 | 97.293 ± 1.8971 |
| Night time, Week 44, n=11 | 97.719 ± 1.6543 |
| Night time, Week 48, n=13 | 93.912 ± 14.0863 |
Average number of night movement episodes per hour for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Number of movements/hour | Mega Faros Device + Fast Fix |
|---|---|
| Week 0, n=24 | 6.129 ± 4.6585 |
| Week 4, n=22 | 6.982 ± 7.6835 |
| Week 8, n=19 | 9.258 ± 17.3296 |
| Week 12, n=16 | 3.803 ± 1.7339 |
| Week 16, n=13 | 6.852 ± 11.6765 |
| Week 20, n=13 | 4.788 ± 4.4738 |
| Week 24, n=14 | 4.216 ± 1.8617 |
| Week 28, n=10 | 5.295 ± 5.1177 |
| Week 32, n=12 | 8.708 ± 12.9217 |
| Week 36, n=10 | 12.149 ± 17.7170 |
| Week 40, n=12 | 4.747 ± 4.5737 |
| Week 44, n=11 | 3.385 ± 1.8031 |
| Week 48, n=13 | 7.209 ± 13.6287 |
Average night-time rest efficiency for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)
| Percentage of time | Mega Faros Device + Fast Fix |
|---|---|
| Week 0, n=24 | 0.986 ± 0.0125 |
| Week 4, n=22 | 0.982 ± 0.0270 |
| Week 8, n=19 | 0.976 ± 0.0498 |
| Week 12, n=16 | 0.991 ± 0.0044 |
| Week 16, n=13 | 0.986 ± 0.0156 |
| Week 20, n=13 | 0.987 ± 0.0118 |
| Week 24, n=14 | 0.991 ± 0.0053 |
| Week 28, n=10 | 0.986 ± 0.0165 |
| Week 32, n=12 | 0.978 ± 0.0322 |
| Week 36, n=10 | 0.971 ± 0.0468 |
| Week 40, n=12 | 0.987 ± 0.0156 |
| Week 44, n=11 | 0.992 ± 0.0040 |
| Week 48, n=13 | 0.978 ± 0.0536 |
Rest Fragmentation Index was computed as movement time (%) divided by number of movement episodes for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Week 0, n=24 | 0.132 ± 0.3384 |
| Week 4, n=22 | 0.649 ± 2.6064 |
| Week 8, n=19 | 0.096 ± 0.2579 |
| Week 12, n=16 | 0.036 ± 0.0316 |
| Week 16, n=13 | 0.291 ± 0.8315 |
| Week 20, n=13 | 0.086 ± 0.1581 |
| Week 24, n=14 | 0.129 ± 0.3213 |
| Week 28, n=10 | 0.113 ± 0.2836 |
| Week 32, n=12 | 0.507 ± 1.1908 |
| Week 36, n=10 | 0.437 ± 1.1594 |
| Week 40, n=12 | 0.541 ± 1.7070 |
| Week 44, n=11 | 0.041 ± 0.0259 |
| Week 48, n=13 | 0.391 ± 1.2979 |
Average duration of movement episodes for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Seconds | Mega Faros Device + Fast Fix |
|---|---|
| Week 0, n=24 | 8.257 ± 2.5147 |
| Week 4, n=22 | 7.664 ± 2.0949 |
| Week 8, n=19 | 8.133 ± 2.8630 |
| Week 12, n=16 | 8.203 ± 2.3391 |
| Week 16, n=13 | 9.485 ± 5.4216 |
| Week 20, n=13 | 10.190 ± 7.2948 |
| Week 24, n=14 | 7.931 ± 1.8877 |
| Week 28, n=10 | 7.610 ± 1.5252 |
| Week 32, n=11 | 10.220 ± 6.3726 |
| Week 36, n=9 | 7.203 ± 0.6451 |
| Week 40, n=11 | 8.025 ± 1.8174 |
| Week 44, n=11 | 7.730 ± 2.3985 |
| Week 48, n=12 | 8.393 ± 2.5605 |
Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Relationship Between Average Number Night Time Movements/Hour Versus Total ALSFRS-R | 0.178 |
Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Relationship Between Average Duration Movement Episodes at Night Versus Total ALSFRS-R | -0.426 |
Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Relationship Between Average Percent Time Night Time Rest Efficiency Versus Total ALSFRS-R | 0.049 |
Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Relationship Between Average Night Time Rest Fragmentation Index Versus Total ALSFRS-R | -0.163 |
Mean Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Week 0, n=23 | 4.1914 ± 2.35370 |
| Week 4, n=21 | 4.2198 ± 2.88326 |
| Week 8, n=15 | 4.2393 ± 2.50840 |
| Week 12, n=15 | 4.2304 ± 2.13905 |
| Week 16, n=12 | 3.7404 ± 1.99810 |
| Week 20, n=12 | 4.6210 ± 3.40720 |
| Week 24, n=12 | 4.2944 ± 2.43365 |
| Week 28, n=10 | 6.1888 ± 5.64815 |
| Week 32, n=10 | 5.0398 ± 3.64394 |
| Week 36, n=9 | 4.9206 ± 3.44514 |
| Week 40, n=11 | 4.6117 ± 2.81758 |
| Week 44, n=11 | 3.8315 ± 2.29689 |
| Week 48, n=11 | 4.4358 ± 2.56115 |
Variance of Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Week 0, n=23 | 6.3439 ± 6.55782 |
| Week 4, n=21 | 6.8401 ± 6.49766 |
| Week 8, n=15 | 5.3481 ± 4.86394 |
| Week 12, n=15 | 11.4190 ± 11.42238 |
| Week 16, n=12 | 16.1974 ± 20.59606 |
| Week 20, n=12 | 10.2248 ± 13.69276 |
| Week 24, n=12 | 6.5774 ± 9.07676 |
| Week 28, n=10 | 6.6424 ± 7.53794 |
| Week 32, n=10 | 5.8556 ± 7.19624 |
| Week 36, n=9 | 15.4940 ± 30.00587 |
| Week 40, n=11 | 4.5088 ± 3.56720 |
| Week 44, n=11 | 6.4731 ± 6.29614 |
| Week 48, n=11 | 11.7375 ± 13.64105 |
Mean Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Week 0, n=20 | 5.2011 ± 2.48369 |
| Week 4, n=18 | 5.3944 ± 2.83547 |
| Week 8, n=13 | 5.1733 ± 2.29737 |
| Week 12, n=14 | 6.3760 ± 3.42063 |
| Week 16, n=11 | 6.0905 ± 3.68543 |
| Week 20, n=10 | 6.0958 ± 3.05182 |
| Week 24, n=10 | 6.3113 ± 3.03599 |
| Week 28, n=9 | 5.4652 ± 3.20703 |
| Week 32, n=9 | 8.3196 ± 5.37661 |
| Week 36, n=11 | 6.6827 ± 2.73499 |
| Week 40, n=9 | 4.8166 ± 2.16486 |
| Week 44, n=9 | 5.6220 ± 2.61752 |
| Week 48, n=7 | 5.8935 ± 3.22033 |
Variance of Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Week 0, n=20 | 6.3439 ± 6.55782 |
| Week 4, n=18 | 6.8401 ± 6.49766 |
| Week 8, n=13 | 5.3481 ± 4.86394 |
| Week 12, n=14 | 11.4190 ± 11.42238 |
| Week 16, n=11 | 16.1974 ± 20.59606 |
| Week 20, n=10 | 10.2248 ± 13.69276 |
| Week 24, n=10 | 6.5774 ± 9.07676 |
| Week 28, n=9 | 6.6424 ± 7.53794 |
| Week 32, n=9 | 5.8556 ± 7.19624 |
| Week 36, n=11 | 15.4940 ± 30.00587 |
| Week 40, n=9 | 4.5088 ± 3.56720 |
| Week 44, n=9 | 6.4731 ± 6.29614 |
| Week 48, n=7 | 11.7375 ± 13.64105 |
Mean Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data is not available. Standard deviation could not be calculated when number of participants was \<=1
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Week 0, n=2 | 4.3350 ± 0.09192 |
| Week 4, n=1 | 3.8100 ± NA |
Variance of Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Week 0, n=2 | 0.0000 ± 0.0000 |
| Week 4, n=1 | 0.0000 ± NA |
The effect of being upright on mean HRV was calculated as \[mean HRV while sedentary not lying minus mean HRV while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Week 0, n=20 | 1.0563 ± 2.12227 |
| Week 4, n=18 | 1.3507 ± 2.56807 |
| Week 8, n=13 | 1.1937 ± 2.40299 |
| Week 12, n=14 | 2.1585 ± 2.80355 |
| Week 16, n=11 | 2.5080 ± 3.40632 |
| Week 20, n=10 | 2.4613 ± 3.64555 |
| Week 24, n=10 | 2.5161 ± 1.95702 |
| Week 28, n=9 | -0.1964 ± 6.11226 |
| Week 32, n=9 | 3.3476 ± 5.59881 |
| Week 36, n=9 | 2.5583 ± 3.74969 |
| Week 40, n=9 | 0.9722 ± 1.73768 |
| Week 44, n=9 | 1.6069 ± 2.71641 |
| Week 48, n=6 | 1.5796 ± 3.73597 |
The effect of being upright on HRV variance was calculated as \[HRV variance while sedentary not lying minus HRV variance while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Week 0, n=20 | -0.0750 ± 5.21420 |
| Week 4, n=18 | -5.5005 ± 28.71903 |
| Week 8, n=13 | -2.0885 ± 9.89872 |
| Week 12, n=14 | 4.1473 ± 8.03699 |
| Week 16, n=11 | 9.8909 ± 21.83721 |
| Week 20, n=10 | 2.9204 ± 17.31637 |
| Week 24, n=10 | -1.1979 ± 2.96892 |
| Week 28, n=9 | -13.6310 ± 45.52591 |
| Week 32, n=9 | -8.9054 ± 19.69942 |
| Week 36, n=9 | 10.3525 ± 35.50938 |
| Week 40, n=9 | -3.8092 ± 8.66934 |
| Week 44, n=9 | -2.1221 ± 11.81571 |
| Week 48, n=6 | 4.3165 ± 16.66785 |
The effect of activity on mean HRV was calculated as \[mean HRV while sedentary not lying minus mean HRV while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1.
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Week 0; n= 2 | -1.6117 ± 2.88735 |
| Week 4; n= 1 | 0.9367 ± NA |
The effect of activity on HRV variance was calculated as \[HRV variance while sedentary not lying minus HRV variance while lying\] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was \<=1.
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Week 0; n= 2 | -8.6500 ± 5.93027 |
| Week 4; n= 1 | -3.4367 ± NA |
Mean HRV over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Milliseconds^2 | Mega Faros Device + Fast Fix |
|---|---|
| Week 0, n=24 | 21.2445 ± 6.13882 |
| Week 4, n=21 | 20.0394 ± 6.61338 |
| Week 8, n=15 | 22.4551 ± 5.98867 |
| Week 12, n=16 | 20.6744 ± 6.95469 |
| Week 16, n=12 | 20.7926 ± 7.01048 |
| Week 20, n=12 | 20.7321 ± 6.80432 |
| Week 24, n=12 | 21.3250 ± 6.92749 |
| Week 28, n=10 | 21.7888 ± 7.14731 |
| Week 32, n=10 | 21.1318 ± 8.08213 |
| Week 36, n=11 | 20.8849 ± 5.72665 |
| Week 40, n=11 | 20.0684 ± 7.98572 |
| Week 44, n=11 | 20.2980 ± 5.95832 |
| Week 48, n=12 | 19.5152 ± 8.04882 |
HRV variance over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Milliseconds^2 | Mega Faros Device + Fast Fix |
|---|---|
| Week 0, n=24 | 35.3316 ± 25.70628 |
| Week 4, n=21 | 26.2719 ± 19.19169 |
| Week 8, n=15 | 34.5477 ± 18.01341 |
| Week 12, n=16 | 31.8929 ± 28.36635 |
| Week 16, n=12 | 34.8321 ± 25.62477 |
| Week 20, n=12 | 41.4669 ± 36.88159 |
| Week 24, n=12 | 34.3781 ± 38.27469 |
| Week 28, n=10 | 45.4243 ± 62.35269 |
| Week 32, n=10 | 30.5288 ± 24.91715 |
| Week 36, n=11 | 24.8373 ± 14.41668 |
| Week 40, n=11 | 18.4227 ± 9.54924 |
| Week 44, n=11 | 22.5279 ± 10.78475 |
| Week 48, n=12 | 15.7176 ± 13.15760 |
Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that sample size was insufficient to calculate correlation coefficient
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Mean HRV effect of being upright v/s ALSFRS-R;n=24 | 0.139 |
| Mean LF/HF (lying down) (1) v/s ALSFRS-R;n=25 | 0.228 |
| Mean LF/HF sedentary (not lying) v/s ALSFRS-R;n=24 | 0.023 |
| Var. LF/HF sedentary (not lying) v/s ALSFR-R;n=24 | -0.041 |
| Mean HRV effect of activity v/s ALSFRS-R;n=3 | 0.421 |
| Mean LF/HF (avg-daytime activity) v/s ALSFRS-R;n=3 | -0.921 |
| Var of HRV effect of activity v/s ALSFRS-R;n=3 | 0.419 |
| Var of HRV effect being upright v/s ALSFRS-R;n=24 | 0.308 |
| Var of LF/HF (lying down) v/s ALSFRS-R;n=25 | -0.378 |
| Var of LF/HF v/s ALSFRS-R;n=3 | NA |
Speech quality was assessed by Central Tendency of Fundamental Frequency (CTF) F0, jitter, and shimmer for 'short ah' and 'long ah' tests. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Hertz | Mega Faros Device + Fast Fix |
|---|---|
| CTF F0;Week0;n=25 (Short ah) | 151.829 ± 44.5983 |
| CTF F0;Week12;n=18 (Short ah) | 156.506 ± 42.0801 |
| CTF F0;Week24;n=17 (Short ah) | 143.481 ± 43.8646 |
| CTF F0;Week36;n=15 (Short ah) | 151.192 ± 43.1685 |
| CTF F0;Week48;n=18 (Short ah) | 156.418 ± 71.9125 |
| CTF F0;EWD;n=3 (Short ah) | 176.229 ± 76.2851 |
| Jitter;Week0;n=25 (Short ah) | 0.405 ± 0.2814 |
| Jitter;Week12;n=18 (Short ah) | 0.531 ± 0.2956 |
| Jitter;Week24;n=17 (Short ah) | 0.415 ± 0.3345 |
| Jitter;Week36;n=15 (Short ah) | 0.429 ± 0.2987 |
| Jitter;Week48;n=18 (Short ah) | 0.379 ± 0.2949 |
| Jitter;EWD;n=2 (Short ah) | 0.435 ± 0.1835 |
| Shimmer;Week0;n=25 (Short ah) | 5.099 ± 1.0892 |
| Shimmer;Week12;n=18 (Short ah) | 5.031 ± 1.0850 |
| Shimmer;Week24;n=17 (Short ah) | 5.498 ± 1.1896 |
| Shimmer;Week36;n=15 (Short ah) | 5.203 ± 1.4083 |
| Shimmer;Week48;n=18 (Short ah) | 5.157 ± 1.9564 |
| Shimmer;EWD;n=2 (Short ah) | 5.624 ± 1.5979 |
| CTF F0;Week0;n=25 (Long ah) | 134.443 ± 33.2237 |
| CTF F0;Week12;n=18 (Long ah) | 122.620 ± 35.6641 |
| CTF F0;Week24;n=17 (Long ah) | 146.295 ± 63.0013 |
| CTF F0;Week36;n=15 (Long ah) | 145.575 ± 45.5629 |
| CTF F0;Week48;n=18 (Long ah) | 134.198 ± 48.3046 |
| CTF F0;EWD;n=3 (Long ah) | 179.844 ± 25.7371 |
| Jitter;Week0;n=25 (Long ah) | 0.148 ± 0.1701 |
| Jitter;Week12;n=18 (Long ah) | 0.098 ± 0.0697 |
| Jitter;Week24;n=17 (Long ah) | 0.178 ± 0.3030 |
| Jitter;Week36;n=15 (Long ah) | 0.229 ± 0.3069 |
| Jitter;Week48;n=18 (Long ah) | 0.148 ± 0.1309 |
| Jitter;EWD;n=2 (Long ah) | 0.304 ± 0.3115 |
| Shimmer;Week0;n=25 (Long ah) | 2.926 ± 1.0166 |
| Shimmer;Week12;n=18 (Long ah) | 3.192 ± 0.8599 |
| Shimmer;Week24;n=17 (Long ah) | 3.082 ± 1.1959 |
| Shimmer;Week36;n=15 (Long ah) | 2.872 ± 1.2162 |
| Shimmer;Week48;n=18 (Long ah) | 3.046 ± 1.4476 |
| Shimmer;EWD;n=2 (Long ah) | 2.767 ± 0.0709 |
Duration of maximum gap between words during running speech to planned to analyze quality of speech however; was not performed.
No measurements were reported for this outcome.
Speaking rate was analyzed during running speech. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Words per minute | Mega Faros Device + Fast Fix |
|---|---|
| Week0; n=25 | 151.490 ± 42.3137 |
| Week12; n=18 | 160.628 ± 46.2482 |
| Week24; n=17 | 153.958 ± 45.2931 |
| Week36; n=15 | 166.342 ± 67.6138 |
| Week48; n=18 | 138.984 ± 65.6871 |
| EWD; n=2 | 179.687 ± 27.6064 |
Phoneme rate was analyzed for the single word "doily". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Hertz per second | Mega Faros Device + Fast Fix |
|---|---|
| Week0; n=25 | 6176.377 ± 2196.778 |
| Week12; n=18 | 6903.574 ± 2484.952 |
| Week24; n=17 | 5859.531 ± 3433.272 |
| Week36; n=15 | 6937.497 ± 4868.936 |
| Week48; n=18 | 5738.519 ± 3410.358 |
| EWD; n=2 | 8980.240 ± 709.4459 |
Maximum phonation time for the single word "doily" test was analyzed for quality of speech testing. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Seconds | Mega Faros Device + Fast Fix |
|---|---|
| Week0; n=25 | 0.174 ± 0.0724 |
| Week12; n=18 | 0.188 ± 0.0862 |
| Week24; n=17 | 0.186 ± 0.1005 |
| Week36; n=15 | 0.154 ± 0.0608 |
| Week48; n=18 | 0.147 ± 0.0884 |
| EWD; n=2 | 0.212 ± 0.0639 |
Percentage pause time for running speech was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Percentage of time | Mega Faros Device + Fast Fix |
|---|---|
| Week0; n=25 | 31.900 ± 17.1724 |
| Week12; n=18 | 26.609 ± 8.1333 |
| Week24; n=17 | 30.177 ± 14.3137 |
| Week36; n=15 | 24.410 ± 9.5753 |
| Week48; n=18 | 23.991 ± 11.8426 |
| EWD; n=2 | 24.042 ± 0.3466 |
Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Repeated Measures Correlation Coefficient has been presented in the table below
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| Jitter (%) (Short ah) v/s ALSFRS-R | 0.137 |
| CTF F0 (Long ah) v/s ALSFRS-R | -0.154 |
| Jitter (%) (Long ah) v/s ALSFRS-R | 0.119 |
| Shimmer(%) (Long ah) v/s ALSFRS-R | 0.138 |
| Maximum Phonation Time v/s ALSFRS-R | 0.152 |
Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Between Subject Correlation Coefficient has been presented in the table below
| Ratio | Mega Faros Device + Fast Fix |
|---|---|
| CTF F0 (Short ah) v/s FVC | -0.214 |
| Jitter (%) (Short ah) v/s FVC | 0.143 |
| Shimmer(%) (Short ah) v/s FVC | -0.080 |
| CTF F0 (Long ah) v/s FVC | -0.504 |
| Jitter (%) (Long ah) v/s FVC | -0.321 |
| Shimmer(%) (Long ah) v/s FVC | -0.327 |
| Average Phoneme Rate v/s FVC | 0.453 |
| Maximum Phonation Time v/s FVC | -0.215 |
| Percent Pause Time v/s FVC | -0.376 |
| Speaking Rate v/s FVC | 0.547 |
Participant's feedback on whether the sensor was comfortable to wear was categorized as "yes" and "no". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Participants | Mega Faros Device + Fast Fix |
|---|---|
| Sensor comfortable to wear;Pilot; n=5;Yes | 4 |
| Sensor comfortable to wear;Pilot; n=5;No | 1 |
| Sensor comfortable to wear;Pilot repeat; n=5;Yes | 3 |
| Sensor comfortable to wear;Pilot repeat; n=5;No | 2 |
| Sensor comfortable to wear;Week12; n=15;Yes | 14 |
| Sensor comfortable to wear;Week12; n=15;No | 1 |
| Sensor comfortable to wear;Week24; n=14; Yes | 13 |
| Sensor comfortable to wear;Week24; n=14;No | 1 |
| Sensor comfortable to wear;Week36; n=14; Yes | 12 |
| Sensor comfortable to wear;Week36; n=14; No | 2 |
| Sensor comfortable to wear;Week48; n=18; Yes | 14 |
| Sensor comfortable to wear;Week48; n=18;No | 4 |
| Sensor comfortable to wear;EWD; n=2;Yes | 0 |
| Sensor comfortable to wear;EWD; n=2;No | 2 |
Participant feedback on how much the sensor impacted their sleep was categorized as "not at all", "moderately" and "minimally". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Participants | Mega Faros Device + Fast Fix |
|---|---|
| Not at all;Pilot; n=5 | 4 |
| Moderately;Pilot; n=5 | 1 |
| Minimally; Pilot; n=5 | 0 |
| Not at all;Pilot repeat; n=5 | 3 |
| Moderately;Pilot repeat; n=5 | 2 |
| Minimally; Pilot repeat; n=5 | 0 |
| Not at all;Week12; n=15 | 15 |
| Moderately;Week12; n=15 | 0 |
| Minimally; Week12; n=15 | 0 |
| Not at all;Week24; n=14 | 12 |
| Moderately;Week24; n=14 | 0 |
| Minimally; Week24; n=14 | 2 |
| Not at all;Week36; n=14 | 12 |
| Moderately;Week36; n=14 | 0 |
| Minimally; Week36; n=14 | 2 |
| Not at all;Week48; n=18 | 15 |
| Moderately;Week48; n=18 | 0 |
| Minimally; Week48; n=18 | 3 |
| Not at all;EWD; n=2 | 1 |
| Moderately;EWD; n=2 | 1 |
| Minimally; EWD; n=2 | 0 |
The participants were required to give feedback on how easy was it to set up and/ or attach the sensor and it was categorized as "easy", "neutral" and "difficult". Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Participants | Mega Faros Device + Fast Fix |
|---|---|
| Easy;Pilot; n=5 | 4 |
| Neutral;Pilot; n=5 | 1 |
| Difficult;Pilot; n=5 | 0 |
| Easy;Pilot repeat; n=5 | 5 |
| Neutral;Pilot repeat; n=5 | 0 |
| Difficult;Pilot repeat; n=5 | 0 |
| Easy;Week0; n=25 | 23 |
| Neutral;Week0; n=25 | 2 |
| Difficult;Week0; n=25 | 0 |
| Easy;Week4; n=23 | 23 |
| Neutral;Week4; n=23 | 0 |
| Difficult;Week4; n=23 | 0 |
| Easy;Week8; n=21 | 19 |
| Neutral;Week8; n=21 | 0 |
| Difficult;Week8; n=21 | 2 |
| Easy;Week12; n=20 | 18 |
| Neutral;Week12; n=20 | 2 |
| Difficult;Week12; n=20 | 0 |
| Easy;Week16; n=18 | 15 |
| Neutral;Week16; n=18 | 2 |
| Difficult;Week16; n=18 | 1 |
| Easy;Week20; n=20 | 15 |
| Neutral;Week20; n=20 | 2 |
| Difficult;Week20; n=20 | 3 |
| Easy;Week24; n=18 | 15 |
| Neutral;Week24; n=18 | 2 |
| Difficult;Week24; n=18 | 1 |
| Easy;Week28; n=16 | 12 |
| Neutral;Week28; n=16 | 2 |
| Difficult;Week28; n=16 | 2 |
| Easy;Week32; n=20 | 15 |
| Neutral;Week32; n=20 | 3 |
| Difficult;Week32; n=20 | 2 |
| Easy;Week36; n=18 | 14 |
| Neutral;Week36; n=18 | 3 |
| Difficult;Week36; n=18 | 1 |
| Easy;Week40; n=15 | 10 |
| Neutral;Week40; n=15 | 3 |
| Difficult;Week40; n=15 | 2 |
| Easy;Week44; n=16 | 13 |
| Neutral;Week44; n=16 | 1 |
| Difficult;Week44; n=16 | 2 |
| Easy;Week48; n=15 | 8 |
| Neutral;Week48; n=15 | 3 |
| Difficult;Week48; n=15 | 4 |
The activity level required by the participant to complete their job was recorded, and was categorized as Not working, Physical activity required, and Sedentary. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Participants | Mega Faros Device + Fast Fix |
|---|---|
| Pilot; Not working;n=5 | 1 |
| Pilot; Physical activity required;n=5 | 2 |
| Pilot; Sedentary;n=5 | 2 |
| Pilot repeat; Not working;n=5 | 1 |
| Pilot Repeat; Physical activity required;n=5 | 0 |
| Pilot Repeat; Sedentary;n=5 | 4 |
| Week0; Not working;n=25 | 10 |
| Week0; Physical activity required;n=25 | 10 |
| Week0; Sedentary;n=25 | 5 |
| Week4; Not working;n=23 | 8 |
| Week4; Physical activity required;n=23 | 7 |
| Week4; Sedentary;n=23 | 8 |
| Week8; Not working;n=21 | 12 |
| Week8; Physical activity required;n=21 | 5 |
| Week8; Sedentary;n=21 | 4 |
| Week12; Not working;n=20 | 8 |
| Week12; Physical activity required;n=20 | 5 |
| Week12; Sedentary;n=20 | 7 |
| Week16; Not working;n=18 | 11 |
| Week16; Physical activity required;n=18 | 3 |
| Week16; Sedentary;n=18 | 4 |
| Week20; Not working;n=20 | 11 |
| Week20; Physical activity required;n=20 | 5 |
| Week20; Sedentary;n=20 | 4 |
| Week24; Not working;n=18 | 11 |
| Week24; Physical activity required;n=18 | 4 |
| Week24; Sedentary;n=18 | 3 |
| Week28; Not working;n=16 | 9 |
| Week28; Physical activity required;n=16 | 2 |
| Week28; Sedentary;n=16 | 5 |
| Week32; Not working;n=20 | 11 |
| Week32; Physical activity required;n=20 | 5 |
| Week32; Sedentary;n=20 | 4 |
| Week36; Not working;n=18 | 11 |
| Week36; Physical activity required;n=18 | 3 |
| Week36; Sedentary;n=18 | 4 |
| Week40; Not working;n=15 | 7 |
| Week40; Physical activity required;n=15 | 7 |
| Week40; Sedentary;n=15 | 1 |
| Week44; Not working;n=16 | 8 |
| Week44; Physical activity required;n=16 | 4 |
| Week44; Sedentary;n=16 | 4 |
| Week48; Not working;n=15 | 7 |
| Week48; Physical activity required;n=15 | 4 |
| Week48; Sedentary;n=15 | 4 |
Average activity level during the time of wearing the sensor was reported by the participants, and was categorized as very low level activity, low level activity, moderate level activity and high level activity. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Participants | Mega Faros Device + Fast Fix |
|---|---|
| Pilot;Very low level activity;n=5 | 0 |
| Pilot; Low level activity; n=5 | 2 |
| Pilot;Moderate level activity;n=5 | 3 |
| Pilot;High level activity;n=5 | 0 |
| Pilot repeat;Very low level activity;n=5 | 1 |
| Pilot repeat; Low level activity; n=5 | 2 |
| Pilot repeat;Moderate level activity;n=5 | 2 |
| Pilot repeat;High level activity;n=5 | 0 |
| Week0;Very low level activity;n=25 | 2 |
| Week0;Low level activity;n=25 | 6 |
| Week0;Moderate level activity;n=25 | 14 |
| Week0;High level activity;n=25 | 3 |
| Week4;Very low level activity;n=23 | 2 |
| Week4;Low level activity;n=23 | 9 |
| Week4;Moderate level activity;n=23 | 11 |
| Week4;High level activity;n=23 | 1 |
| Week8;Very low level activity;n=21 | 0 |
| Week8;Low level activity;n=21 | 11 |
| Week8;Moderate level activity;n=21 | 9 |
| Week8;High level activity;n=21 | 1 |
| Week12;Very low level activity;n=20 | 2 |
| Week12;Low level activity;n=20 | 11 |
| Week12;Moderate level activity;n=20 | 6 |
| Week12;High level activity;n=20 | 1 |
| Week16;Very low level activity;n=18 | 1 |
| Week16;Low level activity;n=18 | 9 |
| Week16;Moderate level activity;n=18 | 8 |
| Week16;High level activity;n=18 | 0 |
| Week20;Very low level activity;n=20 | 0 |
| Week20;Low level activity;n=20 | 14 |
| Week20;Moderate level activity;n=20 | 5 |
| Week20;High level activity;n=20 | 1 |
| Week24;Very low level activity;n=18 | 0 |
| Week24;Low level activity;n=18 | 10 |
| Week24;Moderate level activity;n=18 | 7 |
| Week24;High level activity;n=18 | 1 |
| Week28;Very low level activity;n=16 | 1 |
| Week28;Low level activity;n=16 | 10 |
| Week28;Moderate level activity;n=16 | 3 |
| Week28;High level activity;n=16 | 2 |
| Week32;Very low level activity;n=20 | 4 |
| Week32;Low level activity;n=20 | 10 |
| Week32;Moderate level activity;n=20 | 4 |
| Week32;High level activity;n=20 | 2 |
| Week36;Very low level activity;n=18 | 3 |
| Week36;Low level activity;n=18 | 9 |
| Week36;Moderate level activity;n=18 | 3 |
| Week36;High level activity;n=18 | 3 |
| Week40;Very low level activity;n=15 | 3 |
| Week40;Low level activity;n=15 | 7 |
| Week40;Moderate level activity;n=15 | 4 |
| Week40;High level activity;n=15 | 1 |
| Week44;Very low level activity;n=16 | 2 |
| Week44;Low level activity;n=16 | 8 |
| Week44;Moderate level activity;n=16 | 6 |
| Week44;High level activity;n=16 | 0 |
| Week48;Very low level activity;n=15 | 2 |
| Week48;Low level activity;n=15 | 7 |
| Week48;Moderate level activity;n=15 | 5 |
| Week48;High level activity;n=15 | 1 |
The participants reported whether the sensor fell off. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Participants | Mega Faros Device + Fast Fix |
|---|---|
| Pilot;Yes;n=5 | 0 |
| Pilot;No;n=5 | 5 |
| Pilot Repeat;Yes;n=5 | 1 |
| Pilot Repeat;No;n=5 | 4 |
| Week 0; Yes; n=25 | 0 |
| Week 0; No; n=25 | 25 |
| Week 4; Yes;n=23 | 2 |
| Week 4;No; n=23 | 21 |
| Week 8; Yes; n=21 | 4 |
| Week 8; No; n=21 | 17 |
| Week 12; Yes;n=20 | 1 |
| Week 12;No;n=20 | 19 |
| Week 16;Yes; n=18 | 0 |
| Week 16;No; n=18 | 18 |
| Week 20; Yes; n=20 | 1 |
| Week 20; No; n=20 | 19 |
| Week 24;Yes; n=18 | 2 |
| Week 24;No; n=18 | 16 |
| Week 28;Yes; n=16 | 1 |
| Week 28;No; n=16 | 15 |
| Week 32;Yes; n=20 | 1 |
| Week 32;No; n=20 | 19 |
| Week 36;Yes; n=18 | 0 |
| Week 36;No; n=18 | 18 |
| Week 40;Yes; n=15 | 1 |
| Week 40;No; n=15 | 14 |
| Week 44;Yes; n=16 | 0 |
| Week 44;No; n=16 | 16 |
| Week 48;Yes; n=15 | 0 |
| Week 48;No; n=15 | 15 |
Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE.
| Participants | Mega Faros Device + Fast Fix |
|---|---|
| AEs | 6 |
| SAEs | 0 |
Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Number of AEs, SAEs and Adverse events leading to discontinuation (AELDs)from the study is presented
| Events | Mega Faros Device + Fast Fix |
|---|---|
| AEs | 6 |
| SAEs | 0 |
Collected over On-treatment SAEs and non-serious AEs were collected from start of study treatment until Week 48.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mega Faros Device + Fast Fix | 0/25 (0%) | 0/25 (0%) | 6/25 (24%) |
| Event | Mega Faros Device + Fast Fix |
|---|---|
| Dermatitis contactSkin and subcutaneous tissue disorders | 4/25 |
| RashSkin and subcutaneous tissue disorders | 2/25 |
| Rash pruriticSkin and subcutaneous tissue disorders | 1/25 |
| Skin irritationSkin and subcutaneous tissue disorders | 1/25 |
| Age, Continuous(Years) | Mega Faros Device + Fast Fix |
|---|---|
| Mean | 53.1 ± 9.93 |
| Sex: Female, Male(Participants) | Mega Faros Device + Fast Fix |
|---|---|
| Female | 4 |
| Male | 21 |
| Race/Ethnicity, Customized(Participants) | Mega Faros Device + Fast Fix |
|---|---|
| Asian - East Asian Heritage | 1 |
| Asian - South East Asian Heritage | 1 |
| White - White/Caucasian/European Heritage | 23 |
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