Combination Tonsillectomy and Hypoglossal Nerve Stimulation for OSA Patients With Lateral Pharyngeal Collapse

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07724938
Status
Not Yet Recruiting

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Conditions

  • Obstructive Sleep Apnea
  • Sleep Disordered Breathing

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tonsillectomy — PROCEDURE
    Tonsillectomy
  • HGNS — DEVICE
    HGNS alone (without concomitant tonsillectomy)

Study Details

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

Key Dates

First listed
Jul 24, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2030
Completion
Feb 28, 2031

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HGNS plus tonsillectomy
    HGNS plus concomitant tonsillectomy
  • Active Comparator: 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

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-

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Brigham and Women's Hospital· Boston, MA

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