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Could a mouthpiece tame a heart rhythm disorder?

NCT ID NCT03835429

Disease control Sponsor: Texas A&M University 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small pilot study tested whether a special oral appliance (like a mouthguard) could reduce episodes of atrial fibrillation, a common heart rhythm problem. Only 3 people participated, and the study was ended early. The device is already used for snoring and sleep apnea, but its effect on heart rhythm remains unclear.

What this could mean

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

Active substance
MyTAP oral appliance plus mouth shield (a dental device that moves the jaw forward)
What this could lead to
If it works, this could point toward a non-invasive way to help control atrial fibrillation in some patients.
What could go wrong
This was a tiny pilot study with only 3 participants and was terminated early, so results are very limited. The device is not proven to treat atrial fibrillation.

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

3 people

The number who actually took part.

Started

Jan 2019

Finished

Jan 2025

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: * Pre-qualified for ablation AF intervention * AF \> 1 documented episode in a 24-hour electrocardiogram (ECG) Holter examination or implanted AF monitor in the previous 1 month prior to study enrollment; \[AF episode defined as at least 12 hours duration\] * At least 8 teeth per arch to support OA device * Use of continuous positive air pressure (CPAP)therapy and willingness to switch to OA use * Willing and able to provide verbal and written informed consent * Ability to understand how to apply and utilize the sleep recorder and the OA device Exclusion Criteria: * Patients with implantable cardiac rhythm device \[pacemakers or internal cardiac device (ICDs)\] or cardiopulmonary disease \[heart failure, Chronic obstructive pulmonary disease (COPD), ventricular dysrhythmia\] * Unable or unwilling to complete the study demands and schedule * Comorbidities of other sleep disorders other than OSA * No active temporomandibular joint disorders (TMD) or jaw muscle pain, or morphological airway abnormalities * Pre-existing difficulty swallowing; throat or neck related health issues; endocrine dysfunction; severe psychiatric and neurological disorders; intellectually disabled; handicaps limiting sleep position * Previous OA therapy or restrictions in jaw opening * Prior ablation of AF, myocardial infarction (MI), stroke or decompensation of heart failure within the last six months, untreated overt hyper- or hypothyroidism * Commencement of new anti-arrhythmic drug since last monitor check * Pharmacological dependency * Concomitant use of hypnotic agents or other sleep aids, nicotine or alcohol intake * Mallampati score \> III * Palatine tonsils - grade \> 2 * History of Uvulopalatopharyngoplasty (UPPP) surgery

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Conditions

The condition(s) this trial relates to.

atrial fibrillation sleep apnea syndrome Snoring

As listed by the trial registrant

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

Atrial fibrillation

Contacts and locations

Locations

  • Texas A&M School of Dentistry, Health Science Center

    Dallas, Texas, 75246, United States

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