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Mouth gadget may cut bathroom trips for sleep apnea sufferers

NCT ID NCT05562388

Symptom relief Sponsor: Isabel Moreno Hay Source: ClinicalTrials.gov ↗

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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 This study
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 Results may not be published yet.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)
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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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study tested whether a dental mouthpiece (mandibular advancement device) can reduce frequent nighttime urination in adults with obstructive sleep apnea. Eleven participants who woke up to pee at least twice a night used the device and tracked their bathroom visits. The goal was to see if the device could cut nighttime urination to fewer than two times per night.

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

11 people

The number who actually took part.

Started

Dec 2023

Finished

Jul 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 to 80 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: * English speaker * \>18 y/o * Obstructive sleep apnea diagnosis with AHI≥5 * ≥ 2 voiding/night at baseline * Upon clinical examination ≥ 8 teeth per arch, range of mandibular protrusion ≥5 mm * Consent to participate in the study. Exclusion Criteria: * Patients with concomitant diagnosed sleep disorders (i.e. insomnia, narcolepsy, restless legs syndrome, rapid eye movement sleep behavior disorder). * Prostate/kidney problems (urological disease: (eg overactive bladder, benign prostate hyperplasia) * Pregnancy * Heart failure, use of diuretics, diabetes, Parkinson's disease or dementia. * Patients using combination therapy for the management of obstructive sleep apnea (OSA) (i.e. positive airway pressure (PAP) therapy or positional therapy). * Upon clinical examination: periodontal disease (\>4 mm on periodontal probing, with bleeding on probing, visual signs of periodontal inflammation); tooth horizontal mobility \>1 mm, vertical mobility, and unfavorable crown to root ratio; open cavities, loose or fractured restorations, or patient undergoing restorative dental treatments. * Exaggerated gag reflex. * Lack of coordination or dexterity. * Inadequate English comprehension.

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Conditions

The condition(s) this trial relates to.

Nocturia obstructive sleep apnea syndrome

As listed by the trial registrant

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

Nocturia Obstructive sleep apnea OSA

Contacts and locations

Locations

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

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