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NCT Number: NCT07714330

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peninsula Sleep Center

Burlingame, California, 94010, United States

Location status: Recruiting

Location contact

Mehran Farid, M.D.

CONTACT

[email protected]

650-779 4055

Mehran Farid, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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/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
  • 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
  • BMI >35
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Proportion of participants with supine sleep percentage of less than 15%

    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.

  2. Self-reported Comfort, Overnight Retention, and Ease of Device Use

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Roland, M.D.

CONTACT

[email protected]

Michael Swertfager

CONTACT

[email protected]

408-499-6884

Sponsors and collaborators

Lead sponsor

SleepDev, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2026
Registry last updated
Jul 21, 2026

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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