Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/10/2018 |
| Start Date: | August 2014 |
| End Date: | August 2015 |
Investigation of a Novel Sleep Surface for Treatment of Positional Sleep Apnea.
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.
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.
(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.
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
We found this trial at
1
site
2050 Kenny Road
Columbus, Ohio 43221
Columbus, Ohio 43221
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