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Sleep apnea study tests coaching to boost mouth guard use

NCT ID NCT04092660

Symptom relief Sponsor: Queen Mary University of London 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether extra support—like a health pamphlet, a video, and motivational counseling—helps people with obstructive sleep apnea use their mandibular advancement appliance (a mouth guard) more consistently. Fifty-six adults (age 40+) with sleep apnea will be randomly assigned to receive either the extra support or standard care. Their mouth guard use will be tracked for 6 months using a micro-sensor and sleep diaries.

What this could mean

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

Active substance
behavioural support (health pamphlet, video, and motivational counseling)
What this could lead to
If it works, this could point toward simple ways to help people with sleep apnea stick with their mouth guard treatment, improving their sleep and health.
What could go wrong
This is a small, early-stage study (56 people) testing a behavioural intervention, not a new drug or device. The extra support may not make a meaningful difference in how often people use the mouth guard.

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 56 people

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

Started

Dec 2019

Expected to finish

Jun 2026

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

40 to 90 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: * Adult (≥ 40 years old) * Confirmed diagnosis of OSA (AHI ≥ 5) * Referred for MAA therapy * Must be able to understand, read and write English; with the assistance of a translator Exclusion Criteria: * Insufficient teeth for MAA fabrication * Poor dental and/or periodontal health * Symptomatic Temporomandibular Disorder (TMD) * Previously used an MAA * Patients with Epilepsy

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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

  • Royal London Dental Hospital

    RECRUITING

    London, E1 2AD, United Kingdom

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