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NCT07724938

Overview

NCT ID: NCT07724938
Lead Sponsor: Brigham and Women's HospitalOTHER
Official Title: Combination Tonsillectomy and Hypoglossal Nerve Stimulation for OSA Patients With Lateral Pharyngeal Collapse
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:

Does hypoglossal nerve stimulation combined with tonsillectomy reduce the severity of obstructive sleep apnea more than hypoglossal nerve stimulation alone?

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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 24, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Aug 2030Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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 Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 72Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Daniel Vena, PhDContact
dvena@bwh.harvard.edu16178520719

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Masking Description

Because treatment assignment determines the surgical procedure and subsequent study schedule, participants, treating surgeons, and study personnel responsible for clinical care, safety monitoring, scheduling, and study operations will not be blinded to treatment assignment. Outcomes assessors (e.g., principal investigator, postdoc fellow) may become aware of treatment assignment through protocol oversight or participant safety monitoring but will not participate in blinded primary outcome scoring. To minimize assessment bias, sleep studies used for the primary endpoint will be prepared by an unblinded study team member not involved in outcome assessment. Files will be assigned blinded assessment identifiers and stripped of treatment assignment and other information that could reveal allocation. Primary endpoint scoring will be performed by personnel blinded to treatment assignment, and the primary analysis will be conducted using coded treatment groups until the analysis is finalized.