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Mouth device offers new hope for sleep apnea patients who Can't use CPAP

NCT ID NCT07132307

Disease control Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a custom mouthpiece (mandibular advancement device) for people with moderate to severe obstructive sleep apnea who cannot tolerate CPAP and have not improved with a nerve stimulation implant. Researchers will measure if the device reduces breathing pauses during sleep. The trial involves 30 adults and uses home sleep tests to check results.

What this could mean

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

Active substance
mandibular advancement device (MAD) - ProSomnus Sleep Device
What this could lead to
If it works, this could offer a new treatment option for people with severe sleep apnea who have not been helped by other therapies.
What could go wrong
This is a small, early study with only 30 people. The device may not work for everyone, and results may not apply to all patients.

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

Jul 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 70 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: * Age ≥ 18 years. * Ability to read, write, speak, and understand English. * Failure of hypoglossal nerve stimulation (HGNS) therapy, defined as intolerance to HGNS or insufficient AHI reduction based on modified Sher criteria while using HGNS. * Ability to insert and remove the mandibular advancement device (MAD) independently. * Ability to complete all study assessments and evaluations, including home sleep apnea tests (HSAT). * Ability to abstain from any other treatment for obstructive sleep apnea (OSA) during the entire study duration. * Access to an internet-connected device (phone, tablet, or laptop) with a camera. Exclusion Criteria: * Age over 70 years. * Inability to use a mandibular advancement device (MAD), defined as having fewer than 9 healthy teeth per dental arch. * Prior intolerance to MAD therapy. * Previous participation in a trial involving the use of oral appliances. * Chronic nasal obstruction. * Dependence on or frequent use of medications that alter consciousness, respiration, or alertness. * Insomnia and/or use of medications to treat insomnia. * Sleep disorders such as narcolepsy, insomnia, restless leg syndrome, or other disorders affecting sleep, and/or use of medications to treat such disorders. * Substance abuse. * Unstable psychiatric disorders. * Current use of a GLP-1 receptor agonist (e.g., Zepbound, Wegovy, Ozempic, Mounjaro) with ongoing, active weight loss at the time of enrollment, or recent dose escalation within the prior 8 weeks.

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome

As listed by the trial registrant

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

Obstructive sleep apnea

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

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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