Evaluating WhisperPT In-Ear Audio Cues for Positional Therapy in Adults with Positional Obstructive Sleep Apnea

What this Trial Is About

Researchers are evaluating an investigational in-ear positional therapy device called WhisperPT for adults with positional obstructive sleep apnea OSA. The study aims to assess whether the device can reduce breathing disturbances by encouraging participants to avoid sleeping on their backs, a position that tends to worsen OSA symptoms. The trial will measure changes in the apnea-hypopnea index AHI and examine participant comfort and ease of use of the device. Participants will first complete a home sleep study using WatchPAT to establish baseline sleep patterns. They will then use the WhisperPT device for a 3-day acclimation period, followed by another WatchPAT home sleep study while using the device to evaluate its effect on sleep position and breathing events. The device works by monitoring head position and delivering gentle audio cues to prompt participants to shift away from back-sleeping. During the study, participants will be assessed for reductions in AHI, percentage of time spent sleeping on the back, and self-reported comfort and ease of use. The primary outcome is the proportion of participants achieving at least a 50% reduction in AHI within about 7 days. Secondary outcomes include the percentage of time spent supine under 15% and participant feedback on the device. Participants must avoid other sleep-disordered breathing treatments and alcohol during study nights. The overall study duration is approximately one week.

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