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

Part of paid clinical trials in Burlingame, California.

Sponsor
SleepDev, Inc
Study ID
NCT07714330
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea (OSA)
  • Positional Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Investigational Positional Therapy Device — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Jun 25, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Positional Therapy Device

Primary Outcome Measure

Participants Achieving ≥50% Reduction in AHI [ Time Frame: Intervention assessment (Night 5), within approximately 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Peninsula Sleep CenterBurlingameCalifornia94010
Mehran Farid, M.D.
[email protected]
650-779 4055
Mehran Farid, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Burlingame, CA

By research site
Peninsula Sleep Center· Burlingame, CA

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