Peninsula Sleep Center
Burlingame, California, 94010, United States
Location status: Recruiting
NCT Number: NCT07714330
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Burlingame, California, 94010, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Participants with cochlear implants or those who will be affected by small magnets in the ear
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.
Time frame: Intervention assessment (Night 5), within approximately 7 days
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 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: Study completion (approximately 7 days)
Participant-reported comfort while wearing the investigational device, overnight device retention, and ease of device use, assessed using the study exit questionnaire.
Contact information is provided by the study sponsor or research team.
Joshua Roland, M.D.
CONTACT
Michael Swertfager
CONTACT
SleepDev, Inc
Industry
Effectiveness of WhisperPT's Audio Cues to Achieve Positional Therapy in Patients With Positional Obstructive Sleep Apnea
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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