An interventional study of Vivalink wearable device in Pulmonary Disease, Chronic Obstructive, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany. Completed at 11 sites in Germany. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Not applicable, Interventional, and Other
The purpose of this multicenter, prospective cohort study is to investigate the correlation of real-world sensor-derived biometric data obtained via a wearable device with clinical parameters and patient-reported outcomes (PROs) for monitoring disease activity and predicting exacerbations for participants with Chronic Obstructive Pulmonary Disease (COPD). The cohort of participants with COPD will be followed for 3 months. A calibration cohort with non-COPD participants will be included and followed for 2 weeks.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 77 is close to the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany is the lead sponsor of 55 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For participants with COPD:
For participants in the calibration cohort:
Exclusion Criteria:
For participants with COPD:
For participants in the calibration cohort:
Device: Vivalink wearable device
Device: Vivalink wearable device
a CE marked device modified to add a temperature measurement algorithm in addition to ECG and respiratory rate measurements
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Physical Activity
An activity flag is extracted from the accelerometer by Vivalink, by using a predefined threshold for adult movement. For stair climbing, first periodic movement was determined, by using frequency analysis on specific time windows, and generating a ratio to the total spectrum indicating periodic activity over a certain threshold.
Time frame: Day 0(Baseline) and Day 8 to Day 14
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate
Heart rate is provided by Vivalink.
Time frame: Day 0(Baseline) and Day 8 to Day 14
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD))
Heart rate variability reflecting differences in time intervals between 2 R-waves in the ECG (milliseconds) SDRR (Standard Deviation of Intervals between Heartbeats), SDNN (Standard Deviation of Intervals between Heartbeats, after removing abnormal Beats), SDNNI (Mean of the Standard Deviations of all the NN intervals for each 5 min Segment of a 24-h HRV Recording), and RMSSD (Mean of the Standard Deviations of all the NN intervals for each 5 min Segment of a 24-hour HRV Recording) and In(RMSDD)
Time frame: Day 0(Baseline) and Day 8 to Day 14
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (pNN50)
pNN50 is the percentage of adjacent NN intervals that differ from each other by more than 50 milliseconds.
Time frame: Day 0(Baseline) and Day 8 to Day 14
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (Stress Index)
Baevsky's Stress Index is a heart rate variability (HRV) measure used to assess autonomic nervous system activity and physiological stress, especially in monitoring chronic obstructive pulmonary disease (COPD) exacerbations. It is calculated as: amplitude of the mode (AMo) divided by two times the mode (Mo) multiplied by the difference between the maximum and minimum RR intervals (MxDMn). AMo is the percentage of RR intervals at the most frequent value, Mo is the most common RR interval, and MxDMn is the range of RR intervals. The index typically ranges from 50 to over 900. Lower values (50-150) indicate low stress and better autonomic balance, while higher values (above 500) reflect increased stress and sympathetic activity. Values above 900 are considered very high stress. This is a single composite score with no subscales; higher scores represent worse outcomes.
Time frame: Day 0(Baseline) and Day 8 to Day 14
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF and HF)
Applying a Fast Fourier Transformation (FFT) or autoregressive (AR) modeling one can separate Heart rate variability (HRV) into its component ultra-low-frequency (ULF), very low frequency (VLF), Low-Frequency power (LF), and High-Frequency power (HF) rhythms that operate within different frequency ranges. Given in absolute values of power (milliseconds squared). LF power, low frequency power (0.04-0.15 Hz). HF power, high frequency power (0.15-0.40 Hz). LF/HF Ratio, spectral HRV index computed as (LF/HF).
Time frame: Day 0(Baseline) and Day 8 to Day 14
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF/HF)
Applying a Fast Fourier Transformation (FFT) or autoregressive (AR) modeling one can separate Heart rate variability (HRV) into its component ultra-low-frequency (ULF), very low frequency (VLF), Low-Frequency power (LF), and High-Frequency power (HF) rhythms that operate within different frequency ranges. Given in absolute values of power (milliseconds squared). LF power, low frequency power (0.04-0.15 Hz). HF power, high frequency power (0.15-0.40 Hz). LF/HF Ratio, spectral HRV index computed as (LF/HF).
Time frame: Day 0(Baseline) and Day 8 to Day 14
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Temperature
Temperature is provided by Vivalink. The value for temperature is derived by Vivalink from the display temperature and then calibrated using initial calibration values, in an IP protected process. The sensor temperature is considered only as a relative value to evaluate changes in the temperature, and not as an objective human body temperature value, meaning no thresholds relative to normal human body temperature are considered, and it will not be used as a marker for fever or hypothermia.
Time frame: Day 0(Baseline) and Day 8 to Day 14
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Respiratory Rate
Respiration rate is provided by Vivalink.
Time frame: Day 0(Baseline) and Day 8 to Day 14
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Cough Frequency
Cough Frequency was provided by vivalink.
Time frame: Day 0(Baseline) and Day 8 to Day 14
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Sleep Patterns
The basis of the sleep pattern calculations is the self-reported bedtimes. With the same technique as the cough frequency prediction, inactivity signals can be predicted from the labeled data to improve the bedtime accuracy, and the changes in accelerometer (step detection algorithms) can be used to quantify the number of clear breaks in the sleep (standing up, strong cough, etc.).
Time frame: Day 0(Baseline) and Day 8 to Day 14
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Resting Heart Rate
Resting Heart Rate is provided by Vivalink.
Time frame: Day 0(Baseline) and Day 8 to Day 14
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Inspiration vs Expiration Time Ratio
Using the breathing signal one can determine the inspiration and expiration peaks. The difference between said peaks in milliseconds can be used to determine the ratio of inspiration (distance from lower point to next peak) vs expiration (distance from peak to next lower point).
Time frame: Day 0(Baseline) and Day 8 to Day 14
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Frequency of Additional Medication
Count of the number of times the use of additional medication as a log activity is reported per day.
Time frame: Day 0(Basseline) and Day 8 to Day 14
Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Accuracy
Accuracy was calculated as (True Positives + True Negatives) / Total Population. True Positives (TP) are events correctly predicted as exacerbations. True Negatives (TN) are events correctly predicted as non-exacerbations. Total Population refers to the total number of events evaluated. Accuracy scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability.
Time frame: Up to 3 months
Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Precision
Precision was calculated as True Positives / (True Positives + False Positives). True Positives (TP) are events correctly predicted as exacerbations. False Positives (FP) are events incorrectly predicted as exacerbations. Total Population refers to the total number of events evaluated. Precision scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability.
Time frame: Up to 3 months
Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Recall
Recall was calculated as True Positives / (True Positives + False Negatives). True Positives (TP) are events correctly predicted as exacerbations. False Negatives (FN) are events incorrectly predicted as non-exacerbations. Total Population refers to the total number of events evaluated. Recall scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability.
Time frame: Up to 3 months
Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Specificity
Specificity was calculated as True Negatives / (True Negatives + False Positives). True Negatives (TN) are events correctly predicted as non-exacerbations. False Positives (FP) are events incorrectly predicted as exacerbations. Total Population refers to the total number of events evaluated. Specificity scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability.
Time frame: Up to 3 months
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Participants health status and symptoms at baseline (Day 0) and study end will be measured as the summary score across items of the CAT questionnaire that consists of 8-items in which participants can choose a score from 0 to 5, for each visit.
Time frame: Baseline (Day 0) and at 3 months
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Lung function was assessed using plethysmography.
Time frame: Baseline (Day 0) and at 3 months
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Lung function was assessed using plethysmography.
Time frame: Baseline (Day 0) and at 3 months
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Lung function was assessed using plethysmography.
Time frame: Baseline (Day 0) and at 3 months
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
Time frame: Baseline (Day 0) and at 3 months
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
Time frame: Baseline (Day 0) and at 3 months
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
Time frame: Baseline (Day 0) and at 3 months
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
Time frame: Baseline (Day 0) and at 3 months
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
Time frame: Baseline (Day 0) and at 3 months
Correlation of Sensor-Collected Data With Number, Date of Onset, and Duration of Mild, Moderate, and Severe Exacerbations
Exacerbations are classified as mild if they are treated with short-acting bronchodilators only, moderate if they are treated additionally with antibiotics or oral corticosteroids, or severe if the patient visits the emergency room or requires hospitalization because of an exacerbation.
Time frame: Up to 3 months
Association Between Sensor Parameters (Heart Rate and Resting Heart Rate) and CAT Score
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Heart Rate and Resting Heart Rate). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
Time frame: 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period)
Association Between Sensor Parameters (Respiration Rate) and CAT Score
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Respiration Rate). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
Time frame: 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) and 14 days before S/M E (1 day window period)
Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
Time frame: 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) and 14 days before S/M E (1 day window period)
Association Between Sensor Parameters (Stress Index, LF/HF) and CAT Score
During the observation period, participants completed the CAT questionnaire daily via a digital app. Stress Index, based on heart rate variability (HRV), assessed autonomic activity and physiological stress. It was calculated as AMo/(2 \* Mo \* MxDMn), where AMo is the % of RR intervals at the most frequent value, Mo is the most common RR interval, and MxDMn is the RR interval range. Stress Index values range from 50-900; lower values (50-150) indicate low stress and better autonomic balance, while higher values (\>500) reflect increased stress and sympathetic activity. LF power reflects sympathetic activity; HF power reflects parasympathetic activity. Linear mixed models assessed associations between CAT score and each sensor parameters. Fixed effect estimates represent change in CAT score per unit change in each parameter. Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI".
Time frame: 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) and 14 days before S/M E (1 day window period)
Association Between Sensor Parameters (pNN50) and CAT Score
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (pNN50). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
Time frame: 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) and 14 days before S/M E (1 day window period)
Association Between Sensor Parameters (Temperature) and CAT Score
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Temperature). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
Time frame: 14 days before S/M E (1 day window period)
Association Between Sensor Parameters (Physical Activity) and CAT Score
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Physical activity). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
Time frame: 14 days before S/M E (1 day window period)
Association Between Sensor Parameters (Sleep Pattern) and CAT Score
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Sleep pattern). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
Time frame: 14 days before S/M E (1 day window period)
Predicting the CAT Score by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates
Patients' health status and symptoms at baseline (Day 0) were measured using the CAT questionnaire, an 8-item tool with scores ranging from 0 to 5 per item. CAT scores were collected daily via a digital application during the observation period. Various machine learning algorithms were evaluated for predictive performance using metrics including accuracy, specificity, sensitivity, precision, positive predictive value (PPV), negative predictive value (NPV), and area under the ROC curve. R² (coefficient of determination) was computed for CAT score prediction models, defined as R² = 1 - (SS\_res / SS\_tot), where SS\_res is the residual sum of squares and SS\_tot is the total sum of squares. R² values range from 0 to 1, with higher values indicating better model fit.
Time frame: Up to 3 months
| Milestone | Calibration Cohort | COPD Cohort |
|---|---|---|
| Started | 10 | 67 |
| Completed | 10 | 64 |
| Not completed | 0 | 3 |
| Withdrew: Not mentioned | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Protocol non-compliance | 0 | 1 |
An activity flag is extracted from the accelerometer by Vivalink, by using a predefined threshold for adult movement. For stair climbing, first periodic movement was determined, by using frequency analysis on specific time windows, and generating a ratio to the total spectrum indicating periodic activity over a certain threshold.
| minutes | COPD Cohort |
|---|---|
| Day 0 | 41.98 ± 22.89 |
| Day 8 to Day 14 | 58.93 ± 33.026 |
Heart rate is provided by Vivalink.
| beats per minute | COPD Cohort |
|---|---|
| Day 0 | 86.4 ± 7.953 |
| Day 8 to Day 14 | 81.26 ± 9.237 |
Heart rate variability reflecting differences in time intervals between 2 R-waves in the ECG (milliseconds) SDRR (Standard Deviation of Intervals between Heartbeats), SDNN (Standard Deviation of Intervals between Heartbeats, after removing abnormal Beats), SDNNI (Mean of the Standard Deviations of all the NN intervals for each 5 min Segment of a 24-h HRV Recording), and RMSSD (Mean of the Standard Deviations of all the NN intervals for each 5 min Segment of a 24-hour HRV Recording) and In(RMSDD)
| milliseconds | COPD Cohort |
|---|---|
| SDRR: Day 0 | 26.83 ± 11.37 |
| SDRR: Day 8-14 | 23.34 ± 10.867 |
| SDNN: Day 0 | 58.71 ± 47.79 |
| SDNN: Day 8-14 | 52.82 ± 39.419 |
| SDNNI: Day 0 | 69.51 ± 63.18 |
| SDNNI: Day 8-14 | 63.18 ± 33.537 |
| RMSSD: Day 0 | 55.37 ± 59.658 |
| RMSSD: Day 8-14 | 53.73 ± 73.024 |
| In (RMSSD): Day 0 | 3.59 ± 0.883 |
| In (RMSSD): Day 8-14 | 3.51 ± 0.813 |
pNN50 is the percentage of adjacent NN intervals that differ from each other by more than 50 milliseconds.
| percentage | COPD Cohort |
|---|---|
| Day 0 | 0.12 ± 0.198 |
| Day 8-14 | 0.11 ± 0.197 |
Baevsky's Stress Index is a heart rate variability (HRV) measure used to assess autonomic nervous system activity and physiological stress, especially in monitoring chronic obstructive pulmonary disease (COPD) exacerbations. It is calculated as: amplitude of the mode (AMo) divided by two times the mode (Mo) multiplied by the difference between the maximum and minimum RR intervals (MxDMn). AMo is the percentage of RR intervals at the most frequent value, Mo is the most common RR interval, and MxDMn is the range of RR intervals. The index typically ranges from 50 to over 900. Lower values (50-150) indicate low stress and better autonomic balance, while higher values (above 500) reflect increased stress and sympathetic activity. Values above 900 are considered very high stress. This is a single composite score with no subscales; higher scores represent worse outcomes.
| ratio | COPD Cohort |
|---|---|
| Day 0 | 108.43 ± 94.236 |
| Day 8-14 | 99.86 ± 81.076 |
Applying a Fast Fourier Transformation (FFT) or autoregressive (AR) modeling one can separate Heart rate variability (HRV) into its component ultra-low-frequency (ULF), very low frequency (VLF), Low-Frequency power (LF), and High-Frequency power (HF) rhythms that operate within different frequency ranges. Given in absolute values of power (milliseconds squared). LF power, low frequency power (0.04-0.15 Hz). HF power, high frequency power (0.15-0.40 Hz). LF/HF Ratio, spectral HRV index computed as (LF/HF).
| hertz | COPD Cohort |
|---|---|
| LF: Day 0 | 320.32 ± 456.411 |
| LF: Day 8-14 | 287.19 ± 399.897 |
| HF: Day 0 | 646.3 ± 1234.891 |
| HF: Day 8-14 | 612.6 ± 1542.947 |
Applying a Fast Fourier Transformation (FFT) or autoregressive (AR) modeling one can separate Heart rate variability (HRV) into its component ultra-low-frequency (ULF), very low frequency (VLF), Low-Frequency power (LF), and High-Frequency power (HF) rhythms that operate within different frequency ranges. Given in absolute values of power (milliseconds squared). LF power, low frequency power (0.04-0.15 Hz). HF power, high frequency power (0.15-0.40 Hz). LF/HF Ratio, spectral HRV index computed as (LF/HF).
| ratio | COPD Cohort |
|---|---|
| LF/HF: Day 0 | 1.38 ± 1.211 |
| LF/HF: Day 8-14 | 1.51 ± 1.204 |
Temperature is provided by Vivalink. The value for temperature is derived by Vivalink from the display temperature and then calibrated using initial calibration values, in an IP protected process. The sensor temperature is considered only as a relative value to evaluate changes in the temperature, and not as an objective human body temperature value, meaning no thresholds relative to normal human body temperature are considered, and it will not be used as a marker for fever or hypothermia.
| celsius | COPD Cohort |
|---|---|
| Day 0 | 36.77 ± 1.155 |
| Day 8 to 14 | 37.14 ± 1.239 |
Respiration rate is provided by Vivalink.
| breaths per minute | COPD Cohort |
|---|---|
| Day 0 | 21.42 ± 1.903 |
| Day 8 to Day 14 | 20.92 ± 2.247 |
Cough Frequency was provided by vivalink.
| count per day | COPD Cohort |
|---|---|
| Day 0 | 56.82 ± 48.46 |
| Day 8 to Day 14 | 72.46 ± 58.62 |
The basis of the sleep pattern calculations is the self-reported bedtimes. With the same technique as the cough frequency prediction, inactivity signals can be predicted from the labeled data to improve the bedtime accuracy, and the changes in accelerometer (step detection algorithms) can be used to quantify the number of clear breaks in the sleep (standing up, strong cough, etc.).
| hours | COPD Cohort |
|---|---|
| Day 0 | 8.7 ± 1.892 |
| Day 8 to Day 14 | 8.48 ± 1.491 |
Resting Heart Rate is provided by Vivalink.
| beats per minute | COPD Cohort |
|---|---|
| Day 0 | 85.02 ± 8.003 |
| Day 8 to Day 14 | 79.9 ± 9.126 |
Using the breathing signal one can determine the inspiration and expiration peaks. The difference between said peaks in milliseconds can be used to determine the ratio of inspiration (distance from lower point to next peak) vs expiration (distance from peak to next lower point).
| ratio | COPD Cohort |
|---|---|
| Day 0 | 0.96 ± 0.078 |
| Day 8 to Day 14 | 0.98 ± 0.068 |
Count of the number of times the use of additional medication as a log activity is reported per day.
| count per day | COPD Cohort |
|---|---|
| Day 0 | 0.37 ± 0.714 |
| Day 8 to Day 14 | 0.82 ± 0.859 |
Accuracy was calculated as (True Positives + True Negatives) / Total Population. True Positives (TP) are events correctly predicted as exacerbations. True Negatives (TN) are events correctly predicted as non-exacerbations. Total Population refers to the total number of events evaluated. Accuracy scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability.
| percentage of predictability | COPD Cohort |
|---|---|
| 70-30 | 0.56 |
| Random | 0.56 |
Precision was calculated as True Positives / (True Positives + False Positives). True Positives (TP) are events correctly predicted as exacerbations. False Positives (FP) are events incorrectly predicted as exacerbations. Total Population refers to the total number of events evaluated. Precision scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability.
| percentage of predictability | COPD Cohort |
|---|---|
| 70-30 | 0.53 |
| Random | 0.62 |
Recall was calculated as True Positives / (True Positives + False Negatives). True Positives (TP) are events correctly predicted as exacerbations. False Negatives (FN) are events incorrectly predicted as non-exacerbations. Total Population refers to the total number of events evaluated. Recall scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability.
| percentage of predictability | COPD Cohort |
|---|---|
| 70-30 | 0.63 |
| Random | 0.46 |
Specificity was calculated as True Negatives / (True Negatives + False Positives). True Negatives (TN) are events correctly predicted as non-exacerbations. False Positives (FP) are events incorrectly predicted as exacerbations. Total Population refers to the total number of events evaluated. Specificity scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability.
| percentage of predictability | COPD Cohort |
|---|---|
| 70-30 | 0.53 |
| Random | 0.63 |
Participants health status and symptoms at baseline (Day 0) and study end will be measured as the summary score across items of the CAT questionnaire that consists of 8-items in which participants can choose a score from 0 to 5, for each visit.
| correlation coefficient | COPD Cohort |
|---|---|
| Baseline: Heart Rate | 0.19 (-0.07 to 0.43) |
| End of Study: Heart Rate | 0.45 (0.16 to 1.67) |
| Baseline: Resting Heart Rate | 0.19 (-0.07 to 0.43) |
| End of Study: Resting Heart Rate | 0.46 (0.16 to 0.68) |
| Baseline: Temperature | 0.07 (-0.19 to 0.32) |
| End of Study: Temperature | 0.02 (-0.31 to 0.33) |
| Baseline: Temperature (normalized) | 0.12 (-0.14 to 0.36) |
| End of Study: Temperature (normalized) | -0.13 (-0.43 to 0.2) |
| Baseline: Respiration Rate | 0.21 (-0.05 to 0.44) |
| End of Study: Respiration Rate | 0.3 (-0.02 to 0.57) |
| Baseline: SDRR | 0.04 (-0.22 to 0.3) |
| End of Study: SDRR | 0.39 (0.08 to 0.63) |
| Baseline: SDNN | -0.06 (-0.31 to 0.21) |
| End of Study: SDNN | 0.38 (0.07 to 0.63) |
| Baseline: SDNNI | 0.02 (-0.24 to 0.28) |
| End of Study: SDNNI | 0.41 (0.09 to 0.65) |
| Baseline: RMSSD | -0.04 (-0.29 to 0.22) |
| End of Study: RMSSD | 0.42 (0.12 to 0.66) |
| Baseline: In (RMSSD) | 0.04 (-0.22 to 0.29) |
| End of Study: In (RMSSD) | 0.44 (0.14 to 0.67) |
| Baseline: pNN50 | -0.06 (-0.31 to 0.2) |
| End of Study: pNN50 | 0.4 (0.09 to 0.64) |
| Baseline: Stress Index | -0.01 (-0.27 to 0.25) |
| End of Study: Stress Index | -0.21 (-0.5 to 0.12) |
| Baseline: LF | -0.28 (-0.5 to -0.03) |
| End of Study: LF | 0.15 (-0.19 to 0.45) |
| Baseline: HF | -0.09 (-0.34 to 0.17) |
| End of Study: HF | 0.18 (-0.16 to 0.47) |
| Baseline: LF/HF | -0.12 (-0.36 to 0.15) |
| End of Study: LF/ HF | -0.34 (-0.6 to -0.01) |
| Baseline: Physical Activity | -0.11 (-0.36 to 0.15) |
| End of Study: Physical Activity | -0.11 (-0.42 to 0.22) |
| Baseline: Physical Activity (normalized) | 0.06 (-0.2 to 0.31) |
| End of Study: Physical Activity (normalized) | 0.11 (-0.22 to 0.42) |
| Baseline: In- vs. Expiration Time Ratio | -0.04 (-0.3 to 0.22) |
| End of Study: In- vs. Expiration Time Ratio | -0.21 (-0.5 to 0.12) |
| Baseline: Cough Frequency | -0.2 (-0.43 to 0.06) |
| End of Study: Cough Frequency | -0.21 (-0.5 to 0.12) |
| Baseline: Cough Frequency (normalized) | 0.06 (-0.2 to 0.31) |
| End of Study: Cough Frequency (normalized) | 0.27 (-0.06 to 0.55) |
Lung function was assessed using plethysmography.
| correlation coefficient | COPD Cohort |
|---|---|
| Baseline: Heart Rate | 0.07 (-0.23 to 0.35) |
| End of Study: Heart Rate | -0.36 (-0.62 to -0.01) |
| Baseline: Resting Heart Rate | 0.08 (-0.22 to 0.36) |
| End of Study: Resting Heart Rate | -0.32 (-0.6 to 0.03) |
| Baseline: Temperature | -0.29 (-0.54 to -0.01) |
| End of Study: Temperature | -0.12 (-0.45 to 0.23) |
| Baseline: Temperature (normalized) | -0.18 (-0.45 to 0.11) |
| End of Study: Temperature (normalized) | 0.1 (-0.25 to 0.43) |
| Baseline: Respiration Rate | -0.25 (-0.5 to 0.04) |
| End of Study: Respiration Rate | -0.24 (-0.54 to 0.11) |
| Baseline: SDRR | -0.28 (-0.53 to 0.01) |
| End of Study: SDRR | -0.31 (-0.6 to 0.04) |
| Baseline: SDNN | 0.15 (-0.14 to 0.42) |
| End of Study: SDNN | -0.17 (-0.49 to 0.19) |
| Baseline: SDNNI | -0.02 (-0.31 to 0.27) |
| End of Study: SDNNI | -0.25 (-0.55 to 0.11) |
| Baseline: RMSSD | 0.08 (-0.21 to 0.36) |
| End of Study: RMSSD | -0.19 (-0.5 to 0.17) |
| Baseline: In (RMSSD) | 0.02 (-0.27 to 0.3) |
| End of Study: In (RMSSD) | -0.17 (-0.49 to 0.19) |
| Baseline: pNN50 | 0.05 (-0.24 to 0.33) |
| End of Study: pNN50 | -0.16 (-0.48 to 0.2) |
| Baseline: Stress Index | -0.04 (-0.32 to 0.25) |
| End of Study: Stress Index | -0.09 (-0.42 to 0.27) |
| Baseline: LF | 0.35 (0.07 to 0.58) |
| End of Study: LF | -0.11 (-0.44 to 0.25) |
| Baseline: HF | 0.18 (-0.11 to 0.45) |
| End of Study: HF | -0.14 (-0.46 to 0.22) |
| Baseline: LF/HF | 0.14 (-0.15 to 0.41) |
| End of Study: LF/ HF | 0.04 (-0.32 to 0.38) |
| Baseline: Physical Activity | 0.11 (-0.18 to 0.39) |
| End of Study: Physical Activity | -0.03 (-0.37 to 0.32) |
| Baseline: Physical Activity (normalized) | -0.09 (-0.37 to 0.2) |
| End of Study: Physical Activity (normalized) | -0.24 (-0.54 to 0.11) |
| Baseline: In- vs. Expiration Time Ratio | 0.29 (0 to 0.53) |
| End of Study: In- vs. Expiration Time Ratio | 0.13 (-0.23 to 0.46) |
| Baseline: Cough Frequency | 0.18 (-0.11 to 0.45) |
| End of Study: Cough Frequency | -0.05 (-0.39 to 0.3) |
| Baseline: Cough Frequency (normalized) | 0.02 (-0.27 to 0.3) |
| End of Study: Cough Frequency (normalized) | -0.2 (-0.51 to 0.15) |
Lung function was assessed using plethysmography.
| correlation coefficient | COPD Cohort |
|---|---|
| Baseline: Heart Rate | 0.11 (-0.18 to 0.38) |
| End of Study: Heart Rate | -0.15 (-0.47 to 0.21) |
| Baseline: Resting Heart Rate | 0.13 (-0.16 to 0.4) |
| End of Study: Resting Heart Rate | -0.11 (-0.44 to 0.24) |
| Baseline: Temperature | -0.21 (-0.47 to 0.08) |
| End of Study: Temperature | -0.28 (-0.57 to 0.07) |
| Baseline: Temperature (normalized) | -0.32 (-0.55 to -0.03) |
| End of Study: Temperature (normalized) | -0.1 (-0.43 to 0.25) |
| Baseline: Respiration Rate | -0.28 (-0.52 to 0.01) |
| End of Study: Respiration Rate | -0.09 (-0.42 to 0.26) |
| Baseline: SDRR | -0.2 (-0.46 to 0.09) |
| End of Study: SDRR | -0.04 (-0.38 to 0.31) |
| Baseline: SDNN | 0.16 (-0.13 to 0.43) |
| End of Study: SDNN | 0.09 (-0.27 to 0.43) |
| Baseline: SDNNI | 0.03 (-0.26 to 0.31) |
| End of Study: SDNNI | 0.04 (-0.31 to 0.38) |
| Baseline: RMSSD | 0.1 (-0.19 to 0.38) |
| End of Study: RMSSD | 0.19 (-0.17 to 0.5) |
| Baseline: In (RMSSD) | 0.04 (-0.25 to 0.32) |
| End of Study: In (RMSSD) | 0.03 (-0.32 to 0.38) |
| Baseline: pNN50 | 0.07 (-0.22 to 0.35) |
| End of Study: pNN50 | 0.21 (-0.15 to 0.52) |
| Baseline: Stress Index | -0.09 (-0.36 to 0.21) |
| End of Study: Stress Index | 0.25 (-0.11 to 0.55) |
| Baseline: LF | 0.31 (0.02 to 0.55) |
| End of Study: LF | 0.29 (-0.06 to 0.58) |
| Baseline: HF | 0.15 (-0.14 to 0.42) |
| End of Study: HF | 0.32 (-0.04 to 0.6) |
| Baseline: LF/HF | 0.25 (-0.04 to 0.5) |
| End of Study: LF/ HF | 0.04 (-0.32 to 0.38) |
| Baseline: Physical Activity | 0.02 (-0.27 to 0.3) |
| End of Study: Physical Activity | 0.11 (-0.24 to 0.44) |
| Baseline: Physical Activity (normalized) | -0.07 (-0.35 to 0.22) |
| End of Study: Physical Activity (normalized) | 0.09 (-0.26 to 0.42) |
| Baseline: In- vs. Expiration Time Ratio | 0.22 (-0.07 to 0.48) |
| End of Study: In- vs. Expiration Time Ratio | 0.02 (-0.33 to 0.36) |
| Baseline: Cough Frequency | 0.16 (-0.13 to 0.43) |
| End of Study: Cough Frequency | -0.16 (-0.47 to 0.2) |
| Baseline: Cough Frequency (normalized) | 0.12 (-0.17 to 0.4) |
| End of Study: Cough Frequency (normalized) | 0.06 (-0.28 to 0.4) |
Lung function was assessed using plethysmography.
| correlation coefficient | COPD Cohort |
|---|---|
| Baseline: Heart Rate | -0.07 (-0.35 to 0.22) |
| End of Study: Heart Rate | -0.3 (-0.59 to 0.04) |
| Baseline: Resting Heart Rate | -0.08 (-0.36 to 0.21) |
| End of Study: Resting Heart Rate | -0.29 (-0.58 to 0.05) |
| Baseline: Temperature | -0.16 (-0.43 to 0.14) |
| End of Study: Temperature | 0.15 (-0.2 to 0.47) |
| Baseline: Temperature (normalized) | 0.07 (-0.22 to 0.35) |
| End of Study: Temperature (normalized) | 0.28 (-0.07 to 0.57) |
| Baseline: Respiration Rate | 0 (-0.29 to 0.28) |
| End of Study: Respiration Rate | -0.22 (-0.52 to 0.14) |
| Baseline: SDRR | -0.27 (-0.51 to 0.02) |
| End of Study: SDRR | -0.42 (-0.67 to -0.08) |
| Baseline: SDNN | -0.08 (-0.36 to 0.21) |
| End of Study: SDNN | -0.28 (-0.57 to 0.08) |
| Baseline: SDNNI | -0.17 (-0.44 to 0.12) |
| End of Study: SDNNI | -0.35 (-0.63 to -0.01) |
| Baseline: RMSSD | -0.09 (-0.37 to 0.2) |
| End of Study: RMSSD | -0.36 (-0.63 to -0.01) |
| Baseline: In (RMSSD) | -0.13 (-0.4 to 0.16) |
| End of Study: In (RMSSD) | -0.23 (-0.53 to 0.13) |
| Baseline: pNN50 | -0.09 (-0.37 to 0.2) |
| End of Study: pNN50 | -0.33 (-0.61 to 0.02) |
| Baseline: Stress Index | 0.09 (-0.2 to 0.37) |
| End of Study: Stress Index | -0.31 (-0.59 to 0.05) |
| Baseline: LF | 0.07 (-0.22 to 0.35) |
| End of Study: LF | -0.31 (-0.59 to 0.05) |
| Baseline: HF | 0.02 (-0.27 to 0.31) |
| End of Study: HF | -0.36 (-0.63 to -0.01) |
| Baseline: LF/HF | -0.06 (-0.34 to 0.23) |
| End of Study: LF/ HF | 0.03 (-0.33 to 0.37) |
| Baseline: Physical Activity | 0.2 (-0.09 to 0.46) |
| End of Study: Physical Activity | -0.15 (-0.47 to 0.2) |
| Baseline: Physical Activity (normalized) | -0.02 (-0.31 to 0.26) |
| End of Study: Physical Activity (normalized) | -0.37 (-0.64 to -0.03) |
| Baseline: In- vs. Expiration Time Ratio | 0.2 (-0.09 to 0.46) |
| End of Study: In- vs. Expiration Time Ratio | 0.17 (-0.19 to 0.49) |
| Baseline: Cough Frequency | -0.02 (-0.31 to 0.27) |
| End of Study: Cough Frequency | 0.1 (-0.25 to 0.43) |
| Baseline: Cough Frequency (normalized) | -0.18 (-0.44 to 0.12) |
| End of Study: Cough Frequency (normalized) | -0.29 (-0.57 to 0.06) |
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
| correlation coefficient | COPD Cohort |
|---|---|
| Baseline: Heart Rate | 0.2 (-0.25 to 0.58) |
| End of Study: Heart Rate | -0.07 (-0.5 to 0.39) |
| Baseline: Resting Heart Rate | 0.21 (-0.24 to 0.59) |
| End of Study: Resting Heart Rate | -0.04 (-0.47 to 0.41) |
| Baseline: Temperature | 0.19 (-0.26 to 0.58) |
| End of Study: Temperature | 0.34 (-0.12 to 0.68) |
| Baseline: Temperature (normalized) | -0.29 (-0.64 to 0.16) |
| End of Study: Temperature (normalized) | 0.38 (-0.08 to 0.7) |
| Baseline: Respiration Rate | 0.42 (-0.02 to 0.72) |
| End of Study: Respiration Rate | -0.06 (-0.49 to 0.4) |
| Baseline: SDRR | 0.12 (-0.33 to 0.53) |
| End of Study: SDRR | -0.01 (-0.46 to 0.44) |
| Baseline: SDNN | 0.22 (-0.24 to 0.59) |
| End of Study: SDNN | 0.21 (-0.27 to 0.61) |
| Baseline: SDNNI | 0.28 (-0.17 to 0.63) |
| End of Study: SDNNI | 0.12 (-0.35 to 0.55) |
| Baseline: RMSSD | 0.31 (-0.14 to 0.65) |
| End of Study: RMSSD | 0.25 (-0.23 to 0.63) |
| Baseline: In (RMSSD) | 0.25 (-0.2 to 0.62) |
| End of Study: In (RMSSD) | 0.32 (-0.16 to 0.68) |
| Baseline: pNN50 | 0.4 (-0.04 to 0.71) |
| End of Study: pNN50 | 0.34 (-0.14 to 0.69) |
| Baseline: Stress Index | 0.02 (-0.42 to 0.45) |
| End of Study: Stress Index | -0.23 (-0.62 to 0.25) |
| Baseline: LF | -0.1 (-0.51 to 0.35) |
| End of Study: LF | 0.37 (-0.1 to 0.71) |
| Baseline: HF | -0.1 (-0.51 to 0.35) |
| End of Study: HF | 0.42 (-0.04 to 0.74) |
| Baseline: LF/HF | -0.07 (-0.49 to 0.37) |
| End of Study: LF/ HF | -0.3 (-0.66 to 0.18) |
| Baseline: Physical Activity | -0.41 (-0.72 to 0.02) |
| End of Study: Physical Activity | -0.19 (-0.59 to 0.27) |
| Baseline: Physical Activity (normalized) | -0.36 (-0.68 to 0.09) |
| End of Study: Physical Activity (normalized) | 0.13 (-0.33 to 0.54) |
| Baseline: In- vs. Expiration Time Ratio | -0.17 (-0.56 to 0.28) |
| End of Study: In- vs. Expiration Time Ratio | -0.05 (-0.49 to 0.41) |
| Baseline: Cough Frequency | 0.02 (-0.41 to 0.45) |
| End of Study: Cough Frequency | 0.26 (-0.21 to 0.63) |
| Baseline: Cough Frequency (normalized) | -0.27 (-0.63 to 0.19) |
| End of Study: Cough Frequency (normalized) | -0.31 (-0.66 to 0.15) |
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
| correlation coefficient | COPD Cohort |
|---|---|
| Baseline: Heart Rate | 0.01 (-0.43 to 0.44) |
| End of Study: Heart Rate | 0.11 (-0.35 to 0.53) |
| Baseline: Resting Heart Rate | 0.02 (-0.41 to 0.45) |
| End of Study: Resting Heart Rate | 0.1 (-0.36 to 0.52) |
| Baseline: Temperature | 0.48 (0.06 to 0.75) |
| End of Study: Temperature | 0.21 (-0.25 to 0.6) |
| Baseline: Temperature (normalized) | 0.08 (-0.36 to 0.5) |
| End of Study: Temperature (normalized) | 0.02 (-0.43 to 0.46) |
| Baseline: Respiration Rate | -0.23 (-0.6 to 0.23) |
| End of Study: Respiration Rate | -0.14 (-0.55 to 0.32) |
| Baseline: SDRR | 0.11 (-0.34 to 0.51) |
| End of Study: SDRR | 0.39 (-0.08 to 0.72) |
| Baseline: SDNN | 0.17 (-0.29 to 0.56) |
| End of Study: SDNN | 0.41 (-0.05 to 0.73) |
| Baseline: SDNNI | 0.24 (-0.21 to 0.61) |
| End of Study: SDNNI | 0.43 (-0.02 to 0.74) |
| Baseline: RMSSD | 0.13 (-0.32 to 0.53) |
| End of Study: RMSSD | 0.25 (-0.23 to 0.63) |
| Baseline: In (RMSSD) | 0.04 (-0.4 to 0.46) |
| End of Study: In (RMSSD) | 0.28 (-0.2 to 0.65) |
| Baseline: pNN50 | 0.08 (-0.37 to 0.49) |
| End of Study: pNN50 | 0.41 (-0.05 to 0.73) |
| Baseline: Stress Index | -0.11 (-0.52 to 0.34) |
| End of Study: Stress Index | -0.32 (-0.67 to 0.16) |
| Baseline: LF | 0.08 (-0.36 to 0.49) |
| End of Study: LF | 0.3 (-0.18 to 0.66) |
| Baseline: HF | 0.24 (-0.22 to 0.61) |
| End of Study: HF | 0.13 (-0.34 to 0.55) |
| Baseline: LF/HF | 0.25 (-0.2 to 0.62) |
| End of Study: LF/ HF | 0.16 (-0.32 to 0.57) |
| Baseline: Physical Activity | -0.26 (-0.62 to 0.2) |
| End of Study: Physical Activity | -0.05 (-0.48 to 0.4) |
| Baseline: Physical Activity (normalized) | -0.16 (-0.55 to 0.3) |
| End of Study: Physical Activity (normalized) | 0.13 (-0.33 to 0.54) |
| Baseline: In- vs. Expiration Time Ratio | -0.34 (-0.68 to 0.1) |
| End of Study: In- vs. Expiration Time Ratio | -0.21 (-0.61 to 0.27) |
| Baseline: Cough Frequency | -0.53 (-0.78 to -0.13) |
| End of Study: Cough Frequency | -0.06 (-0.49 to 0.4) |
| Baseline: Cough Frequency (normalized) | 0.24 (-0.21 to 0.61) |
| End of Study: Cough Frequency (normalized) | 0.4 (0 to 0.74) |
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
| correlation coefficient | COPD Cohort |
|---|---|
| Baseline: Heart Rate | -0.39 (-0.68 to 0.01) |
| End of Study: Heart Rate | -0.3 (-0.65 to 0.15) |
| Baseline: Resting Heart Rate | -0.41 (-0.69 to -0.01) |
| End of Study: Resting Heart Rate | -0.3 (-0.65 to 0.15) |
| Baseline: Temperature | -0.3 (-0.62 to 0.11) |
| End of Study: Temperature | -0.24 (-0.61 to 0.22) |
| Baseline: Temperature (normalized) | 0.02 (-0.38 to 0.41) |
| End of Study: Temperature (normalized) | -0.07 (-0.49 to 0.37) |
| Baseline: Respiration Rate | -0.54 (-0.77 to -0.19) |
| End of Study: Respiration Rate | -0.3 (-0.65 to 0.15) |
| Baseline: SDRR | -0.32 (-0.64 to 0.09) |
| End of Study: SDRR | -0.27 (-0.64 to 0.21) |
| Baseline: SDNN | -0.13 (-0.5 to 0.29) |
| End of Study: SDNN | -0.15 (-0.56 to 0.33) |
| Baseline: SDNNI | -0.2 (-0.56 to 0.22) |
| End of Study: SDNNI | -0.22 (-0.61 to 0.26) |
| Baseline: RMSSD | -0.16 (-0.53 to 0.26) |
| End of Study: RMSSD | -0.08 (-0.51 to 0.39) |
| Baseline: In (RMSSD) | -0.24 (-0.52 to 0.18) |
| End of Study: In (RMSSD) | -0.27 (-0.64 to 0.21) |
| Baseline: pNN50 | -0.14 (-0.52 to 0.28) |
| End of Study: pNN50 | -0.26 (-0.64 to 0.22) |
| Baseline: Stress Index | -0.27 (-0.61 to 0.15) |
| End of Study: Stress Index | 0.37 (-0.1 to 0.71) |
| Baseline: LF | -0.04 (-0.44 to 0.37) |
| End of Study: LF | -0.35 (-0.7 to 0.12) |
| Baseline: HF | -0.09 (-0.48 to 0.32) |
| End of Study: HF | -0.17 (-0.58 to 0.31) |
| Baseline: LF/HF | 0.2 (-0.22 to 0.56) |
| End of Study: LF/ HF | -0.17 (-0.58 to 0.31) |
| Baseline: Physical Activity | 0.47 (0.09 to 0.73) |
| End of Study: Physical Activity | -0.05 (-0.47 to 0.39) |
| Baseline: Physical Activity (normalized) | 0.24 (-0.18 to 0.58) |
| End of Study: Physical Activity (normalized) | -0.17 (-0.56 to 0.28) |
| Baseline: In- vs. Expiration Time Ratio | 0.34 (-0.08 to 0.65) |
| End of Study: In- vs. Expiration Time Ratio | 0.28 (-0.2 to 0.65) |
| Baseline: Cough Frequency | 0.16 (-0.25 to 0.52) |
| End of Study: Cough Frequency | 0.24 (-0.21 to 0.61) |
| Baseline: Cough Frequency (normalized) | 0.03 (-0.37 to 0.42) |
| End of Study: Cough Frequency (normalized) | -0.28 (-0.63 to 0.17) |
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
| correlation coefficient | COPD Cohort |
|---|---|
| Baseline: Heart Rate | 0.16 (-0.25 to 0.52) |
| End of Study: Heart Rate | 0.32 (-0.13 to 0.66) |
| Baseline: Resting Heart Rate | 0.18 (-0.23 to 0.54) |
| End of Study: Resting Heart Rate | 0.3 (-0.16 to 0.64) |
| Baseline: Temperature | 0.13 (-0.28 to 0.5) |
| End of Study: Temperature | -0.26 (-0.62 to 0.2) |
| Baseline: Temperature (normalized) | 0.54 (0.18 to 0.77) |
| End of Study: Temperature (normalized) | -0.55 (-0.8 to -0.16) |
| Baseline: Respiration Rate | 0.09 (-0.31 to 0.47) |
| End of Study: Respiration Rate | 0.15 (-0.3 to 0.55) |
| Baseline: SDRR | -0.04 (-0.43 to 0.37) |
| End of Study: SDRR | 0.14 (-0.33 to 0.56) |
| Baseline: SDNN | -0.13 (-0.51 to 0.29) |
| End of Study: SDNN | -0.12 (-0.55 to 0.35) |
| Baseline: SDNNI | -0.16 (-0.53 to 0.26) |
| End of Study: SDNNI | -0.04 (-0.49 to 0.42) |
| Baseline: RMSSD | -0.14 (-0.51 to 0.28) |
| End of Study: RMSSD | -0.32 (-0.67 to 0.16) |
| Baseline: In (RMSSD) | -0.21 (-0.56 to 0.21) |
| End of Study: In (RMSSD) | -0.29 (-0.66 to 0.19) |
| Baseline: pNN50 | -0.14 (-0.52 to 0.28) |
| End of Study: pNN50 | -0.14 (-0.56 to 0.34) |
| Baseline: Stress Index | 0.45 (0.06 to 0.72) |
| End of Study: Stress Index | 0.14 (-0.34 to 0.56) |
| Baseline: LF | -0.24 (-0.58 to 0.18) |
| End of Study: LF | -0.4 (-0.72 to 0.07) |
| Baseline: HF | -0.1 (-0.48 to 0.32) |
| End of Study: HF | -0.5 (-0.78 to -0.06) |
| Baseline: LF/HF | -0.04 (-0.43 to 0.37) |
| End of Study: LF/ HF | 0.23 (-0.25 to 0.62) |
| Baseline: Physical Activity | -0.41 (-0.69 to -0.02) |
| End of Study: Physical Activity | 0.01 (-0.42 to 0.44) |
| Baseline: Physical Activity (normalized) | -0.13 (-0.5 to 0.28) |
| End of Study: Physical Activity (normalized) | 0.2 (-0.26 to 0.58) |
| Baseline: In- vs. Expiration Time Ratio | -0.3 (-0.63 to 0.11) |
| End of Study: In- vs. Expiration Time Ratio | -0.27 (-0.65 to 0.21) |
| Baseline: Cough Frequency | -0.27 (-0.6 to 0.14) |
| End of Study: Cough Frequency | 0.15 (-0.3 to 0.54) |
| Baseline: Cough Frequency (normalized) | 0 (-0.4 to 0.39) |
| End of Study: Cough Frequency (normalized) | 0.32 (-0.13 to 0.66) |
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
| correlation coefficient | COPD Cohort |
|---|---|
| Baseline: Heart Rate | -0.33 (-0.64 to 0.09) |
| End of Study: Heart Rate | -0.32 (-0.66 to 0.13) |
| Baseline: Resting Heart Rate | -0.35 (-0.66 to 0.06) |
| End of Study: Resting Heart Rate | -0.33 (-0.67 to 0.12) |
| Baseline: Temperature | -0.29 (-0.62 to 0.13) |
| End of Study: Temperature | 0.03 (-0.41 to 0.45) |
| Baseline: Temperature (normalized) | -0.28 (-0.61 to 0.14) |
| End of Study: Temperature (normalized) | 0.04 (-0.4 to 0.46) |
| Baseline: Respiration Rate | -0.28 (-0.61 to 0.14) |
| End of Study: Respiration Rate | -0.28 (-0.64 to 0.17) |
| Baseline: SDRR | -0.46 (-0.73 to -0.06) |
| End of Study: SDRR | -0.37 (-0.7 to 0.11) |
| Baseline: SDNN | -0.13 (-0.51 to 0.3) |
| End of Study: SDNN | -0.35 (-0.69 to 0.13) |
| Baseline: SDNNI | -0.22 (-0.58 to 0.21) |
| End of Study: SDNNI | -0.39 (-0.72 to 0.08) |
| Baseline: RMSSD | -0.11 (-0.5 to 0.32) |
| End of Study: RMSSD | -0.3 (-0.66 to 0.18) |
| Baseline: In (RMSSD) | -0.22 (-0.58 to 0.22) |
| End of Study: In (RMSSD) | -0.36 (-0.7 to 0.11) |
| Baseline: pNN50 | -0.03 (-0.43 to 0.39) |
| End of Study: pNN50 | -0.3 (-0.66 to 0.18) |
| Baseline: Stress Index | -0.36 (-0.68 to 0.06) |
| End of Study: Stress Index | 0.13 (-0.34 to 0.55) |
| Baseline: LF | 0.1 (-0.32 to 0.49) |
| End of Study: LF | -0.11 (-0.54 to 0.36) |
| Baseline: HF | -0.1 (-0.49 to 0.33) |
| End of Study: HF | -0.16 (-0.57 to 0.32) |
| Baseline: LF/HF | 0.29 (-0.14 to 0.63) |
| End of Study: LF/ HF | -0.02 (-0.47 to 0.44) |
| Baseline: Physical Activity | 0.44 (0.04 to 0.72) |
| End of Study: Physical Activity | 0.1 (-0.34 to 0.51) |
| Baseline: Physical Activity (normalized) | 0.17 (-0.25 to 0.53) |
| End of Study: Physical Activity (normalized) | -0.07 (-0.48 to 0.38) |
| Baseline: In- vs. Expiration Time Ratio | 0.45 (0.04 to 0.73) |
| End of Study: In- vs. Expiration Time Ratio | 0.41 (-0.06 to 0.73) |
| Baseline: Cough Frequency | 0.04 (-0.37 to 0.44) |
| End of Study: Cough Frequency | 0.28 (-0.17 to 0.64) |
| Baseline: Cough Frequency (normalized) | -0.11 (-0.5 to 0.3) |
| End of Study: Cough Frequency (normalized) | -0.32 (-0.66 to 0.13) |
Exacerbations are classified as mild if they are treated with short-acting bronchodilators only, moderate if they are treated additionally with antibiotics or oral corticosteroids, or severe if the patient visits the emergency room or requires hospitalization because of an exacerbation.
| correlation coefficient | COPD Cohort |
|---|---|
| Correlation of Sensor-Collected Data With Number, Date of Onset, and Duration of Mild, Moderate, and Severe Exacerbations | NA |
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Heart Rate and Resting Heart Rate). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
| scores on a scale/beats per minute | COPD Cohort |
|---|---|
| 7days<S/M E:Heart Rate | 0.039 (0.016 to 0.063) |
| 7days<S/M E:Resting Heart Rate | 0.039 (0.015 to 0.063) |
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Respiration Rate). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
| scores on a scale/ breaths per minute | COPD Cohort |
|---|---|
| 7days<S/M E:Respiration Rate | 0.370 (0.161 to 0.580) |
| 14days<S/M E:RespirationRate | 0.789 (0.389 to 1.188) |
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
| scores on a scale/millimeter | COPD Cohort |
|---|---|
| 7days<S/M E:SDRR | 0.030 (0.010 to 0.051) |
| 7days<S/M E:SDNN | 0.010 (0.003 to 0.0171) |
| 14days<S/M E:SDNN | 0.029 (0.010 to 0.048) |
| 7days<S/M E:SDNNI | 0.011 (0.003 to 0.018) |
| 14days<S/M E:SDNNI | 0.045 (0.021 to 0.069) |
| 7days<S/M E:RMSSD | 0.006 (0.003 to 0.010) |
| 14days<S/M E:RMSSD | 0.016 (0.004 to 0.027) |
| 7days<S/M E:In (RMSSD) | 0.576 (0.204 to 0.948) |
| 14days<S/M E:In(RMSSD) | 1.893 (1.006 to 2.781) |
During the observation period, participants completed the CAT questionnaire daily via a digital app. Stress Index, based on heart rate variability (HRV), assessed autonomic activity and physiological stress. It was calculated as AMo/(2 \* Mo \* MxDMn), where AMo is the % of RR intervals at the most frequent value, Mo is the most common RR interval, and MxDMn is the RR interval range. Stress Index values range from 50-900; lower values (50-150) indicate low stress and better autonomic balance, while higher values (\>500) reflect increased stress and sympathetic activity. LF power reflects sympathetic activity; HF power reflects parasympathetic activity. Linear mixed models assessed associations between CAT score and each sensor parameters. Fixed effect estimates represent change in CAT score per unit change in each parameter. Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI".
| fixed effect estimate | COPD Cohort |
|---|---|
| 7days<S/M E:Stress Index | 0.003 (0.000 to 0.007) |
| 14days<S/M E:StressIndex | -0.006 (-0.011 to -0.000) |
| 7days<S/M E:LF/HF | -0.441 (-0.703 to -0.179) |
| 14days<S/M E:LF/HF | -0.963 (-1.762 to -0.164) |
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (pNN50). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
| scores on a scale/percent of heartbeats | COPD Cohort |
|---|---|
| 7days<S/M E:pNN50 | 2.259 (0.956 to 3.561) |
| 14days<S/M E:pNN50 | 5.483 (0.723 to 10.242) |
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Temperature). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
| scores on a scale/degree Celsius | COPD Cohort |
|---|---|
| Association Between Sensor Parameters (Temperature) and CAT Score | 0.943 (0.047 to 1.839) |
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Physical activity). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
| scores on a scale/minute | COPD Cohort |
|---|---|
| Association Between Sensor Parameters (Physical Activity) and CAT Score | -0.016 (-0.031 to -0.000) |
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Sleep pattern). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
| scores on a scale/hours per day | COPD Cohort |
|---|---|
| Association Between Sensor Parameters (Sleep Pattern) and CAT Score | -0.292 (-0.571 to -0.014) |
Patients' health status and symptoms at baseline (Day 0) were measured using the CAT questionnaire, an 8-item tool with scores ranging from 0 to 5 per item. CAT scores were collected daily via a digital application during the observation period. Various machine learning algorithms were evaluated for predictive performance using metrics including accuracy, specificity, sensitivity, precision, positive predictive value (PPV), negative predictive value (NPV), and area under the ROC curve. R² (coefficient of determination) was computed for CAT score prediction models, defined as R² = 1 - (SS\_res / SS\_tot), where SS\_res is the residual sum of squares and SS\_tot is the total sum of squares. R² values range from 0 to 1, with higher values indicating better model fit.
| coefficient of determination (R^2) | COPD Cohort |
|---|---|
| Time-Split Model | 82.7 |
| XGBoost regressor model | 82.6 |
Collected over Up to 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Calibration Cohort | 0/67 (0%) | 0/67 (0%) | 0/67 (0%) |
| COPD Cohort | 0/67 (0%) | 3/67 (4.5%) | 3/67 (4.5%) |
| Event | Calibration Cohort | COPD Cohort |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/67 | 2/67 |
| Deep Vein ThrombosisVascular disorders | 0/67 | 1/67 |
| Event | Calibration Cohort | COPD Cohort |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/67 | 2/67 |
| Upper respiratory tract infectionInfections and infestations | 0/67 | 1/67 |
Intention-To-Treat (ITT) population consisted of the following analysis sets: COPD analysis set: all eligible participants with COPD \& Calibration analysis set: all eligible participants with non-COPD
| Age, Continuous(years) | Calibration Cohort | COPD Cohort | Total |
|---|---|---|---|
| Median | 52 (43.75 to 58.75) | 67 (61 to 71.5) | 66 (59 to 71) |
| Sex: Female, Male(Participants) | Calibration Cohort | COPD Cohort | Total |
|---|---|---|---|
| Female | 8 | 37 | 45 |
| Male | 2 | 30 | 32 |
| Race (NIH/OMB)(Participants) | Calibration Cohort | COPD Cohort | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 10 | 67 | 77 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Plan to share: No — We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website http://bit.ly/IPD21
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Pulmonary Disease, Chronic Obstructive→
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany