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

Effectiveness of WhisperPT's 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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea (OSA); Positional Obstructive Sleep Apnea
• Intervention / Treatment: Device: Investigational Positional Therapy Device

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Swertfager; Phone Number: 408-499-6884; Email: mswertfager@sleepdev.com
• Study Contact Backup: Name: Joshua Roland, M.D.; Email: jrolandsleep@gmail.com

Study Locations

• United States
  • California
    • Burlingame, California, United States, 94010
      • Recruiting
      • Peninsula Sleep Center
      • Contact: Mehran Farid, M.D.; Phone Number: 650-779 4055; Email: mehran@peninsulasleep.com
      • Principal Investigator: Mehran Farid, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Investigational Positional Therapy Device

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intervention assessment (Night 5), within approximately 7 days
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.	Study completion (approximately 7 days)

Collaborators and Investigators

• Sponsor: SleepDev, Inc

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Positional Obstructive Sleep Apnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: CIP-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No