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Could removing tonsils supercharge a sleep apnea implant?

NCT ID NCT07724938

Disease control Sponsor: Brigham and Women's Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This trial tests whether removing the tonsils at the same time as implanting a hypoglossal nerve stimulator improves treatment for obstructive sleep apnea in adults whose airway collapses from the side during sleep. Participants are randomly assigned to receive the nerve stimulator either with or without tonsillectomy. The study measures changes in sleep-study results and airway stability to see if the combination offers greater benefit.

What this could mean

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

Active substance
a combination of tonsillectomy (surgical removal of the tonsils) and hypoglossal nerve stimulation (an implanted device that stimulates a nerve to keep the airway open during sleep)
What this could lead to
If the combination works better than nerve stimulation alone, it could offer a more effective surgical option for people with obstructive sleep apnea whose airway collapses from the side.
What could go wrong
This is a relatively small, early-stage trial, and the added benefit of tonsillectomy may be modest or absent. Tonsillectomy carries risks like bleeding, pain, and infection.

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 72 people

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

Started

Sep 2026

Expected to finish

Feb 2031

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: * Age ≥ 18 years * Diagnosis of obstructive sleep apnea with apnea-hypopnea index (AHI) ≥ 15 events/hour * Complete oropharyngeal lateral wall (OPLW) collapse identified on DISE * Candidate for HGNS implantation based on standard clinical criteria * Presence of small (1-2+) tonsils and eligibility for tonsillectomy * Untreated OSA at the time of enrollment * Willing and able to provide written informed consent Exclusion Criteria: * Absence of tonsils * Presence of large tonsils (3-4+; not eligible for HGNS) * Predominant central or mixed sleep apnea (\>25% central or mixed events) * Any unstable or serious medical condition that, in the opinion of the investigator, would increase risk or interfere with study participation * Ineligibility for HGNS implantation based on standard clinical or surgical criteria * Inability to comply with study procedures or follow-up assessments

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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.

Obstructive sleep apnea Sleep disordered breathing

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

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

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