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Botox injection in throat may help sleep apnea sufferers

NCT ID NCT07399782

Disease control Sponsor: Hospital Felicio Rocho 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 injecting botulinum toxin (like Botox) into a throat muscle can help people with moderate to severe obstructive sleep apnea. The goal is to reduce breathing pauses during sleep and improve oxygen levels and daytime sleepiness. The trial involves 20 adults aged 18-50 with a healthy weight and no other major health issues.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Sep 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 to 50 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: * Diagnosis of moderate to severe OSA, confirmed by home or laboratory polysomnography. * Age between 18 and 50 years. * BMI in the range of 18.5-30. * Neck circumference ≤ 44 cm (men) and ≤ 42 cm (women). * Absence of signs of upper obstruction Exclusion Criteria: * Skeletal or craniofacial disorders: * Tonsillar hypertrophy 3-4 * Obesity (BMI \> 30 kg/m²) * Elderly (age \> 50 years) * Neuromuscular diseases (e.g., dystrophies, myasthenia gravis) * Chronic use of medications that alter muscle tone. * Excessive alcohol consumption (\> 14 drinks/week) * Chronic obstructive pulmonary disease (COPD) * Congestive heart failure (NYHA III-IV) or decompensated heart disease. * Concomitant sleep disorders: narcolepsy, restless legs syndrome, sleep behavior disorder (REM). * Predominant central or mixed sleep apnea on polysomnography (≥ 50% central events). * Previous airway surgery (uvulopalatopharyngoplasty, recent tonsillectomy). * Pregnancy or postpartum (\< 6 months). * Neurological conditions: Previous stroke, Parkinson's disease, dementia.

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

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

Sleep apnea syndrome (OSAS) Sleep apnea syndrome, obstructive Sleep apnea, obstructive Sleep apnea/hypopnea syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.