Effectiveness of Audio Cues to Achieve Positional Therapy in Patients With Positional Obstructive Sleep Apnea
Purpose
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.
Conditions
- Obstructive Sleep Apnea (OSA)
- Positional Obstructive Sleep Apnea
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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) - Willing to abstain from use of any other treatments for sleep-disordered breathing beginning at least 3 days prior to at-home study testing and for the remaining duration of their study participation - Between ages 18-75 - Must be able to refrain from alcohol use during nights of at-home study testing - Speaks and reads English sufficiently to understand the study informed consent, study instructions, and study materials - Signs study-specific informed consent form
Exclusion Criteria
- Active medical conditions that would prevent study participation as determined by the principal investigator, including: Inability to easily move from between back and side in both directions Inability to sleep in lateral or supine position due to injury or a medical condition OR inability to sleep in a non-elevated/ tilted bed - 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 - Significant hearing impairment or ear skin issues, including: Participants with cochlear implants or those who will be affected by small magnets in the ear - Suffering from tinnitus - BMI >35 - Current use of any illegal drugs. - Currently pregnant or currently lactating - Current enrollment in a clinical study of any other unapproved investigational drug or device. - Inability or unwillingness to comply with the study requirements. - Any other condition or laboratory value that could, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the participant.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Investigational Positional Therapy Device |
After completing a WatchPAT home sleep study, participants use WhisperPT's positional therapy device for a 3-day acclimation period, followed by a repeat WatchPAT home sleep study with positional therapy in place. |
|
Recruiting Locations
Peninsula Sleep Center
Burlingame, California 94010
Burlingame, California 94010
More Details
- Status
- Recruiting
- Sponsor
- SleepDev, Inc