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Effectiveness of Audio Cues for Positional Obstructive Sleep Apnea

This study is testing an investigational in-ear device called WhisperPT for people with positional obstructive sleep apnea (OSA). If you have OSA, you might experience more breathing problems when sleeping on your back. This device aims to help you sleep in other positions by giving gentle audio cues. Researchers want to see if WhisperPT can reduce your Apnea-Hypopnea Index (AHI), which measures breathing disturbances during sleep, and how comfortable and easy it is to use. To join, you must be 18-75 years old and have a sleep study showing your OSA is significantly worse when sleeping on your back. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 30 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at Intervention assessment (Night 5), within approximately 7 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07714330

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

Recruiting
NAAges 18–75InterventionalTreatment
SleepDev, Inc
~30 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Investigational Positional Therapy Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Participants Achieving ≥50% Reduction in AHI
Measured over Intervention assessment (Night 5), within approximately 7 days

Conditions

Obstructive Sleep Apnea (OSA)
Positional Obstructive Sleep Apnea

Explore related trials

Obstructive Sleep Apnea

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Michael Swertfager · STUDY_CHAIR · SleepDev, Inc
  • Joshua Roland, M.D. · STUDY_DIRECTOR · SleepDev, Inc
  • Mehran Farid, M.D. · PRINCIPAL_INVESTIGATOR

Who to contact

Michael Swertfager
[email protected]
408-499-6884
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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:
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.

What this trial measures

  • Participants Achieving ≥50% Reduction in AHIIntervention 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.