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Adding tonsil removal to nerve stimulation for obstructive sleep apnea

Tests tonsil removal plus hypoglossal nerve stimulation in adults with obstructive sleep apnea.

Key facts

Who runs it
Brigham and Women's Hospital
Where
Boston, United StatesSee the site
Trial code
Registry title
Combination Tonsillectomy and Hypoglossal Nerve Stimulation for OSA Patients With Lateral Pharyngeal Collapse
Status
Recruiting
People taking part
72 people, planned
Started
15 Sept 2026
Expected to end
Feb 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Tonsillectomy
  • HGNS
Record updated
16 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with untreated obstructive sleep apnea whose throat side walls fully collapse during sleep. They will get a nerve stimulation implant (HGNS), with or without tonsil removal.

Age
18 years and older
Sex
All sexes can join
Disease stage
Obstructive sleep apnea with an apnea-hypopnea index (AHI) of 15 events/hour or more. Complete collapse of the side walls of the throat (OPLW) seen on a sleep endoscopy (DISE). Small (1-2+) tonsils.
Earlier treatment
The sleep apnea must not have been treated yet. People must be able to have an HGNS implant and a tonsil removal under standard clinical criteria.

Main reasons for not taking part

  • Tonsils already removed, or large tonsils (3-4+)
  • Mainly central or mixed sleep apnea (more than 25% central or mixed events)
  • Not able to have an HGNS implant under standard clinical or surgical criteria
  • Unstable or serious medical condition that would raise risk or affect taking part
  • Not able to follow study procedures or follow-up visits

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Ineligibility for HGNS implantation based on standard clinical or surgical criteria
  • Any unstable or serious medical condition that, in the opinion of the investigator, would increase risk or interfere with study participation
  • Absence of tonsils
  • Presence of large tonsils (3-4+; not eligible for HGNS)
  • Predominant central or mixed sleep apnea (>25% central or mixed events)
  • Inability to comply with study procedures or follow-up assessments

Where in United States

  • Brigham and Women's HospitalBoston, United StatesContact: Daniel Vena, PhDTaking people

About the trial

What the trial wants to find out

The goal of this clinical trial is to learn whether removing the tonsils at the time of hypoglossal nerve stimulation improves treatment of obstructive sleep apnea in adults whose airway collapses from the side of the upper airway during sleep. The main questions it aims to answer are:

Read full original descriptionShow less

1. Does hypoglossal nerve stimulation combined with tonsillectomy reduce the severity of obstructive sleep apnea more than hypoglossal nerve stimulation alone? 2. Does tonsillectomy improve how effectively hypoglossal nerve stimulation opens and stabilizes the upper airway?

Researchers will compare participants who receive hypoglossal nerve stimulation with tonsillectomy to participants who receive hypoglossal nerve stimulation alone.

Participants will:

* Complete sleep studies, questionnaires, and other assessments before and after treatment * Be randomly assigned to receive hypoglossal nerve stimulation either with or without tonsillectomy * Return for follow-up visits and sleep testing to evaluate treatment effectiveness * In a subset of participants, complete additional overnight testing to measure how treatment changes upper-airway collapsibility

The 2 groups in the trial

  • HGNS plus tonsillectomyTreatment being tested

    HGNS plus concomitant tonsillectomy

    Treatment: Tonsillectomy and HGNS

  • HGNSExisting treatment, for comparison

    HGNS alone (without concomitant tonsillectomy)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Combination Tonsillectomy and Hypoglossal Nerve Stimulation for OSA Patients With Lateral Pharyngeal Collapse
Plain-language title
Adding tonsil removal to nerve stimulation for obstructive sleep apneaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
16 September 2026