Could a whisper in your ear treat sleep apnea?

NCT ID NCT07714330

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This study tests an in-ear device called WhisperPT that plays soft audio cues when a person sleeps on their back, encouraging them to shift position. It is designed for people with positional obstructive sleep apnea, where breathing problems are worse when lying face-up. The trial measures whether the device reduces breathing pauses and time spent back-sleeping, and how comfortable it is to use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an investigational in-ear positional therapy device called WhisperPT that monitors head position and delivers gentle audio cues to discourage back-sleeping
What this could lead to
If effective, this device could offer a comfortable, non-invasive way to manage positional sleep apnea without a mask or bulky equipment.
What could go wrong
This is a small early study with only 30 participants, so results may not apply to everyone. The device may be uncomfortable or fail to consistently reduce back-sleeping.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peninsula Sleep Center

    RECRUITING

    Burlingame, California, 94010, United States

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