Recruiting

Hypoglossal Nerve Stimulation vs. Tonsillectomy

Sponsor:

Brigham and Women's Hospital

Code:

NCT07724938

Conditions

Obstructive Sleep Apnea

Sleep Disordered Breathing

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tonsillectomy

HGNS

Study Details

Brief summary:

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:

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

Conditions

Obstructive Sleep Apnea

Sleep Disordered Breathing

Study ID

NCT07724938

Start date

Sep 15, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2031

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HGNS plus tonsillectomy

HGNS plus concomitant tonsillectomy

active comparator: HGNS

HGNS alone (without concomitant tonsillectomy)

Interventions

Tonsillectomy

Tonsillectomy

HGNS

HGNS alone (without concomitant tonsillectomy)

Primary outcome measure

  • Percent reduction in apnea-hypopnea index (AHI) [ Time Frame: 1 month of optimized therapy. ]

Central Contacts and Locations

Central contacts

Daniel Vena, PhD

16178520719dvena@bwh.harvard.edu

Dillon Gilbertson, BASc

617-732-6488dgilbertson@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 16, 2026

Last verified

Jul, 2026

Keywords

  • Obstructive sleep apnea
  • Hypoglossal nerve stimulation
  • Tonsillectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-09-16.