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Could a mouthpiece replace the CPAP machine for sleep apnea?

NCT ID NCT03924817

Knowledge-focused Sponsor: ResMed Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This registry study follows 500 adults with obstructive sleep apnea who are prescribed a mandibular advancement device (MAD) — a dental appliance worn at night to keep the airway open. Researchers will track how the device is prescribed, how often patients actually use it, and whether it improves breathing and sleep-related quality of life after three months. The goal is to better understand which patients might benefit from this alternative to CPAP therapy.

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 (a dental appliance worn at night to hold the lower jaw forward and keep the airway open)
What this could lead to
If successful, this could help identify which patients with obstructive sleep apnea benefit most from a mandibular advancement device, offering an alternative to CPAP machines.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection and adherence, and the device may not work for everyone.

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.

Participants

About 500 people

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

Started

Feb 2024

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.

Who is studied

Eligible for recruitment are male and female patients of ≥ 18 years who have been diagnosed with OSA and who are not eligible for PAP treatment (no tolerance of PAP therapy, therapy refusal for any reason). Patients who have been prescribed an MAD as treatment for OSA. Patients will be followed in their clinical routine treatment pathway.

Ages

18 to 99 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: * Prescription of any mandibular advancement device * Age ≥ 18 years * Ability to understand the study information and information on usage of personal data * Signed and dated informed consent Exclusion Criteria: * Patients with central sleep apnea (central AI \> 5/hour) * Patients with loose teeth and severe parodontitis * Patients with completely missing teeth or removable tooth replacement, or with a teeth health insufficient to retain an MAD Patients with missing molars Patients with maximum protrusion of less than 5mm

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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

Contacts and locations

Locations

  • Ruhrlandklinik Essen

    Essen, North Rhine-Westphalia, 45239, Germany

  • Schlaf- und Beatmungszentrum Blaubeuren

    Blaubeuren Abbey, Badden-Württemberg, 89143, Germany

  • Universitätsklinikum Regensburg - Klinik für Innere Medizin II

    Regensburg, 93053, Germany

  • Zentrum für Schlafmedizin Dr. Warmuth

    Berlin, State of Berlin, 12683, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.