About this trial
Patients with obstructive sleep apnea (OSA) often experience more frequent and severe breathing disturbances when sleeping in the supine (back-sleeping) position compared with non-supine positions. Positional therapy aims to reduce time spent sleeping in the supine position, but existing treatment options may be limited by comfort and effectiveness. This study evaluates the effectiveness and usability of WhisperPT, an investigational in-ear positional therapy device that delivers gentle audio cues during sleep to encourage participants to move from the supine to a non-supine sleeping position. The study will assess the device's ability to reduce the apnea-hypopnea index (AHI), decrease time spent sleeping supine, and evaluate participant comfort and ease of use.
Eligibility criteria
Qualifiers
Diagnosing sleep study identified a significant positional component to their obstructive sleep apnea (OSA) diagnosis as measured by at least a 50% reduction in Apnea-Hypopnea Index (AHI) while sleeping non-supine compared to supine
Diagnosing sleep study included at least 40% of the night recorded in supine and at least 20% of the night in non-supine position
Have an overall AHI > 10 (4% desaturation)
Diagnosing sleep study included a minimum of 5 hours total sleep time (TST)
Disqualifiers
Requiring medications to sleep
Prior diagnosis of a significant other sleep disorder such as restless leg syndrome/periodic limb movement disorder, primary central sleep apnea, pronounced insomnia, parasomnias, central disorder of hypersomnolence, etc
An active ear infection OR an ear infection within the past month OR a history of >3 ear infections per year
Unusual outer ear, including enlarged or extra small anatomy, that prevents device use
Trial design
Treatments tested in this trial
- Investigational Positional Therapy Device