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

NCT07714330 | Recruiting FDA Device

• 1 other identifier: CIP-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea (OSA); Positional Obstructive Sleep Apnea

Keywords

Positional Obstructive Sleep Apnea

Outcome Measures

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.

  Intervention assessment (Night 5), within approximately 7 days

Secondary Outcomes (2)

• Proportion of participants with supine sleep percentage of less than 15%

  Intervention assessment (Night 5), within approximately 7 days

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

  Study completion (approximately 7 days)

Study Arms (1)

Investigational Positional Therapy Device

EXPERIMENTAL

After completing a WatchPAT home sleep study, participants use WhisperPT's positional therapy device for a 3-day acclimation period, followed by a repeat WatchPAT home sleep study with positional therapy in place.

Device: Investigational Positional Therapy Device

Interventions

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.

Investigational Positional Therapy Device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SleepDev, Inc: lead

Study Sites (1)

Peninsula Sleep Center

Burlingame, California, 94010, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Michael Swertfager

  SleepDev, Inc

  STUDY CHAIR

• Joshua Roland, M.D.

  SleepDev, Inc

  STUDY DIRECTOR

• Mehran Farid, M.D.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Swertfager

CONTACT

408-499-6884; mswertfager@sleepdev.com

Joshua Roland, M.D.

CONTACT

jrolandsleep@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: June 25, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

US (1)