Could a simple mouthguard replace CPAP in a pinch?

NCT ID NCT05939934

Disease control Sponsor: University Hospital, Angers Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a custom mouthpiece (mandibular advancement device) can help people with obstructive sleep apnea when they temporarily stop using their CPAP machine. Forty adults who normally use CPAP will either use the mouthpiece or nothing during a two-week CPAP break. Researchers will measure changes in sleepiness, blood pressure, and heart function to see if the mouthpiece reduces the negative effects of stopping CPAP.

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)
What this could lead to: If it works, this could offer a temporary backup option for sleep apnea patients who need to stop CPAP for a short time.
What could go wrong: This is a small, early-stage trial with only 40 participants. The MAD may not fully prevent symptom return or heart issues during CPAP withdrawal.

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 40 people

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

Started

Mar 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Patient accepting MAD treatment * Patient with an apnea-hypopnea index (AHI) greater than 15 events per hour on the initial recording * Patient with excessive daytime sleepiness during initial treatment (ESE\>10) * Patient treated for more than 12 months by CPAP with average compliance greater than 5 hours per night Exclusion Criteria: * Initial severe daytime sleepiness characterized * OSAS with ≥ 5 central apneas per hour of sleep at baseline recording * Previously diagnosed severe cardiac and/or respiratory pathology: * Body mass index ≥ 35 kg/m2 * Known contraindication to OAM treatment

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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.

Endothelial dysfunction Sleep apnea, obstructive

How to take part

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

The places running it

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

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

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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.

Could a simple mouthguard replace CPAP in a pinch?

What the study statuses mean