Clinical Trial

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

Study acronym: HGNS+T
Not Yet Recruiting
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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
Trial Details
NCT Number NCT07724938
Lead Sponsor Brigham and Women's Hospital
Collaborators: Massachusetts Eye and Ear Infirmary
Conditions Obstructive Sleep Apnea, Sleep Disordered Breathing
Enrollment 72 participants
Start Date 2026-08
Primary Completion 2030-08 (estimated)
Study Completion 2031-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-24