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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Investigational Positional Therapy Device
DeviceThe 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Investigational Positional Therapy DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Participants 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 daysSecondary outcomes
1
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 days2
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)Sponsors and contacts
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Source ClinicalTrials.gov