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Tongue zaps during sleep test could improve apnea therapy

NCT ID NCT03589846

Knowledge-focused Sponsor: Vanderbilt University Medical Center 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 1 time

Summary

This study looks at how stimulating two specific tongue muscles (palatoglossus and genioglossus) affects airway size during a sleep endoscopy procedure. Researchers will measure changes in the airway with and without stimulation in 60 adults with obstructive sleep apnea who cannot use CPAP. The goal is to gather basic data to improve nerve stimulation treatments for sleep apnea.

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 60 people

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

Started

Jul 2018

Expected to finish

Dec 2028

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: 1. Adult patient (≥18 years old) 2. A diagnosis of obstructive sleep apnea as determined by polysomnogram with an apnea-hypopnea index of ≥ 5.0/hr. 3. Intolerant of CPAP therapy due to physical or psychosocial limitations as determined by clinical history 4. Scheduled to undergo DISE as part of routine clinical assessment for further evaluation of pharyngeal anatomy Exclusion Criteria: 1. Unable to consent for research due to a pre-existing neurologic condition as determined by PI 2. Unable to consent for research due to language barriers 3. A history of egg allergy as determined by history or self-reports 4. Currently pregnant as determined by patient report or pre-operative anesthesia evaluation 5. Cardiopulmonary or other medical conditions precluding safe propofol sedation as determined by pre-operative anesthesia evaluation 6. History of palatal or pharyngeal airway surgery including tonsillectomy as determined by clinical history and exam 7. History of radiation treatment to the head or neck as determined by history and/or physical exam

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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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Vanderbilt University Medical Center

    Nashvile, Tennessee, 37232, United States

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