Trial Outcomes & Findings for Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea (NCT NCT02250417)
NCT ID: NCT02250417
Last Updated: 2018-08-08
Results Overview
AHI, or the apnea-hypopnea index, is a numerical measure that accounts for the number of pauses in your breathing per hour of sleep. These breathing disturbances are typically associated with either a brief arousal or awakening from sleep or a 4 percent drop in the blood oxygen levels, called a desaturation. It is used to assess the severity of an individual's sleep apnea. This is measured in each study participant when sleeping with the Wave Sleep Surface and sleeping without the Wave Sleep Surface.
COMPLETED
NA
12 participants
measured during each of the two sleep study sessions (Study Visits 2 and 3)
2018-08-08
Participant Flow
Participant milestones
| Measure |
Sequence 1
Participants randomized to Wave Sleep Surface, then to Non Wave Surface
|
Sequence 2
Participants randomized to Non Wave Sleep Surface, then to the Wave Sleep Surface
|
|---|---|---|
|
First Intervention (1 Night)
STARTED
|
6
|
6
|
|
First Intervention (1 Night)
COMPLETED
|
6
|
6
|
|
First Intervention (1 Night)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Night)
STARTED
|
6
|
6
|
|
Second Intervention (1 Night)
COMPLETED
|
6
|
6
|
|
Second Intervention (1 Night)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea
Baseline characteristics by cohort
| Measure |
All Study Participanrts
n=12 Participants
Participants with positional OSA (based on a previously performed baseline clinical study) were randomized to sleep with or without the Wave sleep surface in a cross-over design. Baseline PSG measures represent values from the previously performed clinical study that qualified subjects to have positional OSA.
|
|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
|
Total AHI
|
14.4 events/hr
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
supine AHI
|
38.1 events/hr
STANDARD_DEVIATION 24.6 • n=5 Participants
|
|
non-supine AHI
|
1.6 events/hr
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Total Sleep Time
|
364.5 mins
STANDARD_DEVIATION 43.8 • n=5 Participants
|
|
Total Recording Time
|
415.7 mins
STANDARD_DEVIATION 32.0 • n=5 Participants
|
|
Sleep Efficiency
|
87.6 %
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Supine Sleep Time
|
153.8 mins
STANDARD_DEVIATION 84.7 • n=5 Participants
|
|
Non-supine Sleep Time
|
210.7 mins
STANDARD_DEVIATION 79.7 • n=5 Participants
|
|
Stage N1 Duration
|
33.3 minutes
STANDARD_DEVIATION 17.0 • n=5 Participants
|
|
Stage N2 Duration
|
255.8 minutes
STANDARD_DEVIATION 48.8 • n=5 Participants
|
|
Stage N3 Duration
|
21.1 minutes
STANDARD_DEVIATION 23.0 • n=5 Participants
|
|
Stage R Duration
|
50.8 minutes
STANDARD_DEVIATION 30.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: measured during each of the two sleep study sessions (Study Visits 2 and 3)Population: The study compares the difference in AHI within each study subject with and without the use of the Wave Sleep Surface during visit 2 and 3 (intention to treat analysis).
AHI, or the apnea-hypopnea index, is a numerical measure that accounts for the number of pauses in your breathing per hour of sleep. These breathing disturbances are typically associated with either a brief arousal or awakening from sleep or a 4 percent drop in the blood oxygen levels, called a desaturation. It is used to assess the severity of an individual's sleep apnea. This is measured in each study participant when sleeping with the Wave Sleep Surface and sleeping without the Wave Sleep Surface.
Outcome measures
| Measure |
Wave Night
n=12 Participants
Results of PSG while sleeping in the sleep laboratory with the Wave sleep surface.
|
Non-Wave Night
n=12 Participants
Results of PSG while sleeping in the sleep laboratory without the Wave sleep surface.
|
|---|---|---|
|
Apnea-hypopnea Index (AHI)- Intention to Treat Analysis
|
9.8 events/hr
Standard Deviation 9.4
|
12.6 events/hr
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: measured during each of the two sleep study sessions (Study Visits 2 and 3)Population: Intention to treat analysis includes data from non-wave night regardless of time spent in supine position compared to baseline polysomnography.
Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3.
Outcome measures
| Measure |
Wave Night
n=12 Participants
Results of PSG while sleeping in the sleep laboratory with the Wave sleep surface.
|
Non-Wave Night
n=12 Participants
Results of PSG while sleeping in the sleep laboratory without the Wave sleep surface.
|
|---|---|---|
|
Objective Sleep Quality
Total Sleep Time
|
379.8 mins
Standard Deviation 31.9
|
363.7 mins
Standard Deviation 23.8
|
|
Objective Sleep Quality
Total Recording Time
|
424.1 mins
Standard Deviation 34.5
|
414.3 mins
Standard Deviation 24.2
|
|
Objective Sleep Quality
Stage N1 duration(lightest sleep stage)
|
38.8 mins
Standard Deviation 19.1
|
36.5 mins
Standard Deviation 17.9
|
|
Objective Sleep Quality
Stage N2 duration(longest sleep stage)
|
261.8 mins
Standard Deviation 34.8
|
259.3 mins
Standard Deviation 19.5
|
|
Objective Sleep Quality
StageN3 duration(deep sleep stage)
|
14.1 mins
Standard Deviation 16.0
|
14.8 mins
Standard Deviation 16.2
|
|
Objective Sleep Quality
Stage R duration(Rapid eye movement or REM)
|
65.0 mins
Standard Deviation 23.1
|
53.1 mins
Standard Deviation 34.7
|
SECONDARY outcome
Timeframe: measured during each of the two sleep study sessions (Study Visits 2 and 3)Population: Intention to treat analysis includes data from non-wave night regardless of time spent in supine position compared to baseline polysomnography.
Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3. Sleep efficiency is defined as the total sleep time divided by the total recording time X100.
Outcome measures
| Measure |
Wave Night
n=12 Participants
Results of PSG while sleeping in the sleep laboratory with the Wave sleep surface.
|
Non-Wave Night
n=12 Participants
Results of PSG while sleeping in the sleep laboratory without the Wave sleep surface.
|
|---|---|---|
|
Sleep Efficiency
|
89.9 percentage of total recording time
Standard Deviation 7.8
|
87.9 percentage of total recording time
Standard Deviation 5.6
|
POST_HOC outcome
Timeframe: Baseline (inclusion) sleep study or the non-Wave night sleep study compared to the Wave Sleep Surface night sleep study.Population: Modified analysis compares the AHI when the time spent in supine position is greater than in the non-supine position either during the baseline sleep study or the non-Wave night.The baseline PSG is the clinical PSG that was the basis of the inclusion to the study performed prior to randomization.
AHI, or the apnea-hypopnea index, is a numerical measure that accounts for the number of pauses in breathing per hour of sleep. These breathing disturbances are typically associated with either a brief arousal or awakening from sleep or a 4 percent drop in the blood oxygen levels, called a desaturation. It is used to assess the severity of an individual's sleep apnea. This is measured in each study participant when sleeping with the Wave Sleep Surface and sleeping without the Wave Sleep Surface. The modified analysis compares the AHI within each participant where time spent in the supine position is greater than time spent in non-supine position from either the baseline (inclusion) sleep study or the non-Wave night sleep study compared to the Wave Sleep Surface night sleep study.
Outcome measures
| Measure |
Wave Night
n=12 Participants
Results of PSG while sleeping in the sleep laboratory with the Wave sleep surface.
|
Non-Wave Night
n=12 Participants
Results of PSG while sleeping in the sleep laboratory without the Wave sleep surface.
|
|---|---|---|
|
Apnea-hypopnea Index (AHI)- Modified Analysis
|
9.8 events/hr
Standard Deviation 9.4
|
15.9 events/hr
Standard Deviation 6.4
|
Adverse Events
Sequence 1
Sequence 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place