Effectiveness of Audio Cues to Achieve Positional Therapy in Patients With Positional Obstructive Sleep Apnea

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSleepDev, Inc

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

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators