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Mouth device vs. CPAP: which works best for sleep apnea?

NCT ID NCT07677332

Disease control Sponsor: University of Copenhagen 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study compares two common treatments for moderate obstructive sleep apnea: a custom mouth device that moves the jaw forward (MAD) and a machine that blows air through a mask (CPAP). Researchers want to see how well each treatment improves breathing during sleep and reduces daytime sleepiness. The trial includes 70 adults with moderate sleep apnea and will also look at side effects like jaw discomfort.

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) and continuous positive airway pressure (CPAP)
What this could lead to
If MAD works as well as CPAP for some patients, it could offer a more comfortable, accessible treatment option for moderate sleep apnea.
What could go wrong
This is a relatively small study (70 people) and MAD may be less effective than CPAP overall. Side effects like jaw pain or bite changes are possible.

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 70 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

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 years and older

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: * Objectively diagnosed with moderate OSA (AHI 15-29) * \>/= 18 years * BMI \</= 35 and neck circumference \<44cm * Fully sanitised at their own dentist (no periodontitis or caries requiring treatment. Periodontal bone loss \<50%) * \>/= 20 teeth. * Evenly distributed occlusal contacts Exclusion Criteria: * Known craniofacial anomalies * General inflammatory joint diseases * Maximal protrusion of the mandible \< 6 mm * Severe deep bite * Anterior open bite * Severe attrition * Severe bruxism and involuntary mandibular movements * Conditions demanding treatment such as temporomandibular disorders (TMD) * Chronically pronounced nasal stenosis * Hypertrophic tonsils (tonsil size 3-4) * Prior blood clot in the brain or in the heart * Heart arrythmias * Other severe systemic diseases * Epilepsia * Allergies towards peanuts, soy or egg * Consumption of morphine or other sedatives which cannot be paused * Pregnant or breast-feeding women

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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 (OSA)

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

  • University of Copenhagen

    Copenhagen, 2200, Denmark

More trials for these conditions

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