NCT07714330 · SleepDev, Inc
Effectiveness of Audio Cues to Achieve Positional Therapy in Patients With Positional Obstructive Sleep Apnea
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Investigational Positional Therapy 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.
Primary outcome measures
Participants Achieving ≥50% Reduction in AHI
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosing sleep study identified a significant positional component to their OSA diagnosis as measured by at least a 50% reduction in 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 Apnea-Hypopnea Index (AHI) \> 10 (4% desaturation)
- Diagnosing sleep study included a minimum of 5 hours total sleep time (TST)
- Willing to abstain from use of any other treatments for sleep disordered breathing beginning at least 3 days prior to at-home study testing and for the remaining duration of their study participation
- Between ages 18-75
- Must be able to refrain from alcohol use during nights of at-home study testing
- Speaks and reads English sufficiently to understand the study informed consent, study instructions, and study materials
- Signs study-specific informed consent form
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
- Requiring medications to sleep
- Prior diagnosis of a significant other sleep disorder such as restless leg syndrome/PLMD, 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
- Significant hearing impairment or ear skin issues, including: Participants with cochlear implants or those who will be affected by small magnets in the ear
- Suffering from tinnitus
- Current use of any illegal drugs.
- Currently pregnant or currently lactating
- Current enrollment in a clinical study of any other unapproved investigational drug or device.
- Inability or unwillingness to comply with the study requirements.
- Any other condition or laboratory value that could, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the participant.
Where
- Burlingame, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 21, 2026 · Source of record for eligibility and locations