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| Name | Class |
|---|---|
| Hill-Rom | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wave Surface, Then Non Wave Surface | Experimental | Subjects sleep first for a whole night in the sleep laboratory with the Wave sleep surface. They then return to the sleep laboratory and sleep without the Wave sleep surface. |
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| Non Wave Surface, Then Wave Surface | Experimental | Subjects sleep first for a whole night in the sleep laboratory without the Wave sleep surface. They then return to the sleep laboratory and sleep with the Wave sleep surface. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wave sleep surface | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | measured during each of the two sleep study sessions (Study Visits 2 and 3) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | measured during each of the two sleep study sessions (Study Visits 2 and 3) |
| Sleep Efficiency |
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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:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Ulysses J Magalang, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Martha Morehouse Medical Pavilion 2050 Kenny Rd;Ste 2600 | Columbus | Ohio | 43221 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Participants randomized to Wave Sleep Surface, then to Non Wave Surface |
| FG001 | Sequence 2 | Participants randomized to Non Wave Sleep Surface, then to the Wave Sleep Surface |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Night) |
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| Second Intervention (1 Night) |
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This is a randomized cross-over study. The same subject slept with and without the Wave sleep surface.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Mean | Standard Deviation | events/hr | measured during each of the two sleep study sessions (Study Visits 2 and 3) |
|
7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sequence 1 | Subjects sleep first for a whole night in the sleep laboratory with the Wave sleep surface. They then return to the sleep laboratory and sleep without the Wave sleep surface. Wave 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ulysses J. Magalang | The Ohio State University | 614-292-6563 | magalang.1@osu.edu |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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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. |
| measured during each of the two sleep study sessions (Study Visits 2 and 3) |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Total AHI | Mean | Standard Deviation | events/hr |
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| supine AHI | Mean | Standard Deviation | events/hr |
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| non-supine AHI | Mean | Standard Deviation | events/hr |
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| Total Sleep Time | Mean | Standard Deviation | mins |
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| Total Recording Time | Mean | Standard Deviation | mins |
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| Sleep Efficiency | Sleep Efficiency=total sleep time divided by total recording time x100 | Mean | Standard Deviation | % |
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| Supine Sleep Time | Mean | Standard Deviation | mins |
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| Non-supine Sleep Time | Mean | Standard Deviation | mins |
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| Stage N1 Duration | Stage N1 is the lightest sleep stage | Mean | Standard Deviation | minutes |
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| Stage N2 Duration | Stage N2 Duration is referred to as the longest sleep stage/largest percentage of sleep time | Mean | Standard Deviation | minutes |
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| Stage N3 Duration | Stage N3 is the referred to as "deep sleep" or "slow wave sleep." | Mean | Standard Deviation | minutes |
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| Stage R Duration | Stage R is the last sleep stage-rapid eye movement (REM) | Mean | Standard Deviation | minutes |
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| OG001 | Non-Wave Night | Results of PSG while sleeping in the sleep laboratory without the Wave sleep surface. |
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| 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. | Intention to treat analysis includes data from non-wave night regardless of time spent in supine position compared to baseline polysomnography. | Posted | Mean | Standard Deviation | mins | measured during each of the two sleep study sessions (Study Visits 2 and 3) |
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| 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. | 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. | Posted | Mean | Standard Deviation | events/hr | Baseline (inclusion) sleep study or the non-Wave night sleep study compared to the Wave Sleep Surface night sleep study. |
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| 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. | Intention to treat analysis includes data from non-wave night regardless of time spent in supine position compared to baseline polysomnography. | Posted | Mean | Standard Deviation | percentage of total recording time | measured during each of the two sleep study sessions (Study Visits 2 and 3) |
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| 6 |
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| 6 |
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| 6 |
| EG001 | Sequence 2 | Subjects sleep first for a whole night in the sleep laboratory without the Wave sleep surface. They then return to the sleep laboratory and sleep with the Wave sleep surface. Wave 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. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Stage N1 duration(lightest sleep stage) |
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| Stage N2 duration(longest sleep stage) |
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| StageN3 duration(deep sleep stage) |
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| Stage R duration(Rapid eye movement or REM) |
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