Sleep Apnea, Obstructive
Conditions
Brief summary
Body position during sleep influences the severity of obstructive sleep apnea (OSA). The AHI is the number of times per hour of sleep that the airway temporarily collapses at the level of the tongue or soft palate. In a significant number of individuals with OSA, the severity of the condition as measured by the apnea-hypopnea index (AHI), increases in the supine (back) position and lowers in the lateral (side) position. This is called positional OSA. The primary objective of this study is to determine whether sleeping with a novel sleep surface (Wave sleep surface) that is used on top of a regular bed reduces the AHI in those with positional OSA.
Detailed description
The primary objective of this study is to determine whether sleeping with the novel device (Wave sleep surface) reduces the AHI in those with supine position-related OSA, also known as positional OSA. A secondary aim is to determine the effects of the sleep surface on subjective and objective measures of sleep in patients with positional OSA.
Interventions
OTHERWave sleep surface
The Wave sleep surface is designed to be used as a bed surface and with any combinations of sleep pillows, bed linens, and bed clothes and intended to avoid the supine position during sleep.
Sponsors
Hill-Rom
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
We will recruit subjects who are: * 18 years of age and above * Willing and able to give informed consent * Prior sleep study done based on previous clinical evaluation by the subject's treating physician in the course of usual clinical care and performed no more than 12 months prior to enrollment that meets the following: * overall AHI 5-30 events/hr * at least 20 minutes of recorded sleep in the supine and nonsupine postures * positional OSA defined as \> 50% reduction in the AHI between the supine and nonsupine postures and AHI \< 5hr in the nonsupine position * central apneas \< 50% of the total number of apneas and hypopneas * Patients who meet the above criteria who have been prescribed CPAP therapy but are non-compliant will be enrolled in the study. CPAP noncompliance will be defined as average nightly use \< 4hrs/night based on a download of the CPAP machine, or self- acknowledged discontinuation of CPAP use.
Exclusion criteria
* Incapable of giving informed consent * Under the age of 18 * Known inability to sleep in the lateral position * Active titration of medication * Excessive alcohol consumption * Excessive alcohol use is defined as: * More than 3 glasses of wine a day * More than 3 beers a day * More than 60 mL of hard liquor a day * Room air oxyhemoglobin saturation \< 88% * Use of home oxygen * Compliant with OSA therapy * Presence of severe daytime sleepiness defined as an Epworth sleepiness scale score \> 16 or a prior history of falling asleep while driving * Unstable medical problem such as uncontrolled hypertension. * Body Mass Index (BMI) \> 45 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-hypopnea Index (AHI)- Intention to Treat Analysis | measured during each of the two sleep study sessions (Study Visits 2 and 3) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Sleep Quality | measured during each of the two sleep study sessions (Study Visits 2 and 3) | 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 | measured during each of the two sleep study sessions (Study Visits 2 and 3) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participanrts 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. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Study Participanrts |
|---|---|
| Age, Continuous | 48.4 years STANDARD_DEVIATION 8.7 |
| non-supine AHI | 1.6 events/hr STANDARD_DEVIATION 1.1 |
| Non-supine Sleep Time | 210.7 mins STANDARD_DEVIATION 79.7 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
| Sleep Efficiency | 87.6 % STANDARD_DEVIATION 7.2 |
| Stage N1 Duration | 33.3 minutes STANDARD_DEVIATION 17 |
| Stage N2 Duration | 255.8 minutes STANDARD_DEVIATION 48.8 |
| Stage N3 Duration | 21.1 minutes STANDARD_DEVIATION 23 |
| Stage R Duration | 50.8 minutes STANDARD_DEVIATION 30.1 |
| supine AHI | 38.1 events/hr STANDARD_DEVIATION 24.6 |
| Supine Sleep Time | 153.8 mins STANDARD_DEVIATION 84.7 |
| Total AHI | 14.4 events/hr STANDARD_DEVIATION 5.8 |
| Total Recording Time | 415.7 mins STANDARD_DEVIATION 32 |
| Total Sleep Time | 364.5 mins STANDARD_DEVIATION 43.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Apnea-hypopnea Index (AHI)- 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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wave Night | Apnea-hypopnea Index (AHI)- Intention to Treat Analysis | 9.8 events/hr | Standard Deviation 9.4 |
| Non-Wave Night | Apnea-hypopnea Index (AHI)- Intention to Treat Analysis | 12.6 events/hr | Standard Deviation 7.3 |
Secondary
Objective Sleep Quality
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wave Night | Objective Sleep Quality | Total Sleep Time | 379.8 mins | Standard Deviation 31.9 |
| Wave Night | Objective Sleep Quality | Stage N1 duration(lightest sleep stage) | 38.8 mins | Standard Deviation 19.1 |
| Wave Night | Objective Sleep Quality | Stage R duration(Rapid eye movement or REM) | 65.0 mins | Standard Deviation 23.1 |
| Wave Night | Objective Sleep Quality | Stage N2 duration(longest sleep stage) | 261.8 mins | Standard Deviation 34.8 |
| Wave Night | Objective Sleep Quality | Total Recording Time | 424.1 mins | Standard Deviation 34.5 |
| Wave Night | Objective Sleep Quality | StageN3 duration(deep sleep stage) | 14.1 mins | Standard Deviation 16 |
| Non-Wave Night | Objective Sleep Quality | Total Recording Time | 414.3 mins | Standard Deviation 24.2 |
| Non-Wave Night | Objective Sleep Quality | Stage R duration(Rapid eye movement or REM) | 53.1 mins | Standard Deviation 34.7 |
| Non-Wave Night | Objective Sleep Quality | Total Sleep Time | 363.7 mins | Standard Deviation 23.8 |
| Non-Wave Night | Objective Sleep Quality | StageN3 duration(deep sleep stage) | 14.8 mins | Standard Deviation 16.2 |
| Non-Wave Night | Objective Sleep Quality | Stage N1 duration(lightest sleep stage) | 36.5 mins | Standard Deviation 17.9 |
| Non-Wave Night | Objective Sleep Quality | Stage N2 duration(longest sleep stage) | 259.3 mins | Standard Deviation 19.5 |
Secondary
Sleep Efficiency
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wave Night | Sleep Efficiency | 89.9 percentage of total recording time | Standard Deviation 7.8 |
| Non-Wave Night | Sleep Efficiency | 87.9 percentage of total recording time | Standard Deviation 5.6 |
Post Hoc
Apnea-hypopnea Index (AHI)- Modified Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wave Night | Apnea-hypopnea Index (AHI)- Modified Analysis | 9.8 events/hr | Standard Deviation 9.4 |
| Non-Wave Night | Apnea-hypopnea Index (AHI)- Modified Analysis | 15.9 events/hr | Standard Deviation 6.4 |