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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The investigational intervention is a non-invasive, investigational in-ear positional therapy device worn in the ear during sleep. The device continuously monitors head position and delivers gentle audio cues when the participant remains in the supine (back-sleeping) position to encourage a return to a non-supine sleeping position. The device is evaluated as part of a structured protocol including baseline assessment, acclimation, and treatment nights.
Peninsula Sleep Center
Burlingame, California, United States
RECRUITINGParticipants Achieving ≥50% Reduction in AHI
Proportion of participants achieving a minimum 50% reduction in apnea-hypopnea index (AHI) during treatment compared with baseline, untreated AHI as measured by the WatchPAT ONE home sleep test.
Time frame: Intervention assessment (Night 5), within approximately 7 days
Proportion of participants with supine sleep percentage of less than 15%
Proportion of participants with less than 15% of total sleep time spent in the supine position during the intervention assessment, as measured by the WatchPAT ONE home sleep test.
Time frame: Intervention assessment (Night 5), within approximately 7 days
Self-reported Comfort, Overnight Retention, and Ease of Device Use
Participant-reported comfort while wearing the investigational device, overnight device retention, and ease of device use, assessed using the study exit questionnaire.
Time frame: Study completion (approximately 7 days)
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