An interventional study of Deliver therapy when the supine position is detected in Obstructive Sleep Apnea, sponsored by Advanced Brain Monitoring, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-04-01.
Sponsored by Advanced Brain Monitoring, Inc. · Not applicable, Interventional, and Treatment
The purpose of this study is to assess the accuracy of Night Shift in the detection of supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep.
The protocol is designed to first evaluate the accuracy of supine vs. non-supine detection in 15 subjects (hereafter referred to as study 1). In study 2, patients who had completed a baseline polysomnography (PSG) with a minimum of four hours of sleep time were to wear the Night Shift for two nights without feedback to confirm their willingness to continue with the study, followed by 28 nights of vibro-tactile position therapy. A follow-up PSG was to be conducted as soon as possible to the completion of the 28-nights of treatment. During enrollment subjects were to complete pre-treatment questionnaires designed to measure daytime sleepiness, insomnia severity, depression, anxiety, and quality of life. The same instruments were completed post-treatment on the morning after the 28th night of treatment. Subjects completed daily logs to confirm device utilization and identify potential non-device related factors that could influence study completion.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's enrollment of 36 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Advanced Brain Monitoring, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The inclusion criteria are:
Exclusion Criteria:
Deliver therapy when the supine position is detected
Device: Deliver therapy when the supine position is detected
Application of vibrotactile feedback to the neck when the supine position is detected
Also known as: Night Shift
Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events
Assess the potential for adverse events by evaluating whether more than 20% of participants chose to terminate the study prior to completing 4 weeks of therapy.
Time frame: Four weeks
Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy
Determine the percentage of participants that exhibited at least a 50% reduction in OSA severity measured by AHI after 4 weeks of therapy.
Time frame: 30-days
Confirmation That Night Shift Accurately Detects Supine Position
Compute the percentage of participants at baseline and at followup in which the Night Shift's measurement of the supine position was within+/- 5% of the percent time supine by video recordings plus chest sensor (gold standard).
Time frame: baseline and 4-weeks later at follow up
Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant
Measure the percentage of nights across the 4 weeks of therapy the Night Shift was worn for a minimum of 5.5 hours/night or the length of time in bed by each participant.
Time frame: four weeks
Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback
Evaluate the percent time supine across four weeks of use and confirm that participants average less than 15% time supine across the four weeks of home use
Time frame: four weeks
Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA
The percentage of compliant participants who show an improved Epworth Sleepiness Score of \>= 2 after 4 weeks of therapy when compared to the baseline score. Epworth scores range from 0 (no daytime somnolence) to 21 being extreme somnolence. A difference of 2 or more indicates some positive benefit from therapy.
Time frame: baseline and followup
Evaluate Impact of Positional Therapy on Quality of Life Scores
Compare the Functional Outcomes of Sleep (FOSQ) scores obtained at baseline and compare to results after 4 weeks of therapy to determine the percentage of compliant participants who demonstrate \>2 point improvement. The FOSQ includes thirty questions with numerically scaled responses which are totaled with an overall score of 1 identifying the most impaired and 120 identifying the least impaired.
Time frame: four weeks
Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake
Compare the epochs staged wake and sleep by the reference standard (polysomnography) to the epochs staged wake and sleep by Night Shift to determine the sleep (sensitivity) and wake (specificity) classification accuracy.
Time frame: baseline and follow-up
Assess the Accuracy of Night Shift's Measurement of Total Sleep Time
Compared the Total Sleep Time (TST) from polysomnography to the Night Shift TST to tally the number of records with differences outside the range (151 to -129) defined by the predicate device.
Time frame: one night
Assess the Accuracy of Night Shift Measurement of Sleep Efficiency
Compare Sleep Efficiency (SE) obtained from PSG and compared to the Night Shift SE to determine if outliers are within the range (19.1 to -17.2%) defined by the predicate device
Time frame: one night
| Milestone | Positional Feedback |
|---|---|
| Started | 36 |
| Completed | 30 |
| Not completed | 6 |
| Withdrew: Did not qualify | 5 |
| Withdrew: Protocol violation | 1 |
Assess the potential for adverse events by evaluating whether more than 20% of participants chose to terminate the study prior to completing 4 weeks of therapy.
| Percentage of participants | Positional Feedback |
|---|---|
| Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events | 100 |
Determine the percentage of participants that exhibited at least a 50% reduction in OSA severity measured by AHI after 4 weeks of therapy.
| percentage of participants | Positional Feedback |
|---|---|
| Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy | 83 |
Compute the percentage of participants at baseline and at followup in which the Night Shift's measurement of the supine position was within+/- 5% of the percent time supine by video recordings plus chest sensor (gold standard).
| percentage of participants | Positional Feedback |
|---|---|
| Baseline accuracy n=35 | 91 |
| Followup accuracy n=30 | 93 |
Measure the percentage of nights across the 4 weeks of therapy the Night Shift was worn for a minimum of 5.5 hours/night or the length of time in bed by each participant.
| Percent of nights | Positional Feedback |
|---|---|
| Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant | 96 (71 to 100) |
Evaluate the percent time supine across four weeks of use and confirm that participants average less than 15% time supine across the four weeks of home use
| % participants averaged < 15% supine | Positional Feedback |
|---|---|
| Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback | 97 |
The percentage of compliant participants who show an improved Epworth Sleepiness Score of \>= 2 after 4 weeks of therapy when compared to the baseline score. Epworth scores range from 0 (no daytime somnolence) to 21 being extreme somnolence. A difference of 2 or more indicates some positive benefit from therapy.
| percentage of participants | Positional Feedback |
|---|---|
| Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA | 50 |
Compare the Functional Outcomes of Sleep (FOSQ) scores obtained at baseline and compare to results after 4 weeks of therapy to determine the percentage of compliant participants who demonstrate \>2 point improvement. The FOSQ includes thirty questions with numerically scaled responses which are totaled with an overall score of 1 identifying the most impaired and 120 identifying the least impaired.
| Percentage of participants | Positional Feedback |
|---|---|
| Evaluate Impact of Positional Therapy on Quality of Life Scores | 57 |
Compare the epochs staged wake and sleep by the reference standard (polysomnography) to the epochs staged wake and sleep by Night Shift to determine the sleep (sensitivity) and wake (specificity) classification accuracy.
| percentage of epochs | Positional Feedback |
|---|---|
| Sensitivity sleep baseline | 88.7 ± 8.9 |
| Sensitivity sleep followup | 91.3 ± 8.0 |
| Specificity wake baseline | 55.0 ± 17.7 |
| Specificity wake followup | 61.2 ± 16.5 |
Compared the Total Sleep Time (TST) from polysomnography to the Night Shift TST to tally the number of records with differences outside the range (151 to -129) defined by the predicate device.
| % of studies | Positional Feedback |
|---|---|
| Assess the Accuracy of Night Shift's Measurement of Total Sleep Time | 98 |
Compare Sleep Efficiency (SE) obtained from PSG and compared to the Night Shift SE to determine if outliers are within the range (19.1 to -17.2%) defined by the predicate device
| % studies | Positional Feedback |
|---|---|
| Assess the Accuracy of Night Shift Measurement of Sleep Efficiency | 92 |
Collected over Throughout the study duration i.e., four weeks of use. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Positional Feedback | — | 0/36 (0%) | 0/36 (0%) |
36 subjects were studied at baseline, 5 were dropped due to not meeting the required continuation criteria, 1 was dropped due to not following the protocol requirements. Follow-up PSG studies were conducted and data are available from the 30 participants who completed the study.
| Age, Continuous(years) | Positional Feedback |
|---|---|
| Mean | 50 ± 9.4 |
| Sex: Female, Male(Participants) | Positional Feedback |
|---|---|
| Female | 9 |
| Male | 27 |
| Region of Enrollment(participants) | Positional Feedback |
|---|---|
| United States | 36 |
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Advanced Brain Monitoring, Inc.