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Simple morning trick may stop sleep apnea device from ruining your bite

NCT ID NCT07103941

Prevention Sponsor: Isabel Moreno Hay 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests two simple ways to prevent bite changes in people using a mouthpiece for sleep apnea or snoring. Some participants will use a special aligner each morning to gently guide their jaw back into place, while others will do daily jaw exercises. The goal is to see which method better prevents the back teeth from not meeting properly. The study will follow 30 adults for 3 months with dental scans and surveys.

What this could mean

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

Active substance
AM Aligner (interocclusal aligner device)
What this could lead to
If it works, this could point toward a simple morning routine to prevent unwanted bite changes in people using a mandibular advancement device for sleep apnea.
What could go wrong
This is a very small, early study with only 30 participants and a short 3-month follow-up. Results may not apply to everyone, and the aligner or exercises may not prevent bite changes as hoped.

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

Nov 2025

Expected to finish

Dec 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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 participants (≥18 years) * diagnosed with SRBD and prescribed Mandibular Advancement Device (MAD) therapy * Participants will include patients with well restored natural dentition with all posterior teeth, excluding third molars, one missing premolar secondary to orthodontic treatment. Exclusion Criteria: * pervious orthognathic surgery * anterior cross bite * posterior cross bite * existing open bite or implant supported restorations * tooth mobility * significant dental caries or periodontitis * severe bruxism * planned upcoming dental work including caps, crowns, implants, or braces * inadequate mandibular protrusion * severe micrognathia * large tori * significant claustrophobia * significant nasal obstruction * large oropharyngeal masses or large tonsils

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome Open Bite sleep apnea syndrome Snoring Tooth Migration primary failure of tooth eruption prevention target

As listed by the trial registrant

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

Obstructive sleep apnea (OSA) Occlusal changes Open bite Posterior open bite Sleep related breathing disorder Snoring Tooth migration

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

  • Orofacial Pain Center - University of Kentucky - Kentucky Clinic

    RECRUITING

    Lexington, Kentucky, 40536, United States

More trials for these conditions

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