Tonsillectomy + Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea
(HGNS+T Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Are You a Good Fit for This Trial?
This trial is for adults (18+) with moderate to severe obstructive sleep apnea who have untreated OSA, small tonsils, and a specific type of airway collapse seen during a sleep test. Participants must be eligible for hypoglossal nerve stimulation surgery and able to follow study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive hypoglossal nerve stimulation with or without tonsillectomy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including sleep studies and patient-reported outcomes
Optional Mechanistic Substudy
A subset of participants undergoes detailed physiological sleep studies to measure pharyngeal collapsibility
What Are the Treatments Tested in This Trial?
Interventions
- Hypoglossal Nerve Stimulation (HGNS)
- Tonsillectomy
Trial Overview
The study compares two treatments: one group gets both hypoglossal nerve stimulation (HGNS) and tonsil removal surgery, while the other group receives HGNS alone. Participants are randomly assigned to each group and monitored before and after treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
HGNS plus concomitant tonsillectomy
HGNS alone (without concomitant tonsillectomy)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Massachusetts Eye and Ear Infirmary
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.