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

NCT07724938 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2026P000343
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

Obstructive sleep apnea; Hypoglossal nerve stimulation; Tonsillectomy

Outcome Measures

Primary Outcomes (1)

• Percent reduction in apnea-hypopnea index (AHI)

  Percent reduction in the apnea-hypopnea index (AHI), measured by overnight polysomnography, from baseline to the primary follow-up sleep study. Higher values indicate greater improvement in obstructive sleep apnea.

  1 month of optimized therapy.

Secondary Outcomes (3)

• Absolute change in apnea-hypopnea index

  1 month of optimized therapy.

• Treatment success

  1 month of optimized therapy

• Change in Sleep Apnea Hypoxic Burden from Baseline

  1 month of optimized therapy

Other Outcomes (6)

• PROMIS Sleep Disturbance

  1 month of optimized therapy

• PROMIS Sleep-Related Impairment

  1 month of optimized therapy

• PROMIS Fatigue

  1 month of optimized therapy

Study Arms (2)

HGNS plus tonsillectomy

EXPERIMENTAL

HGNS plus concomitant tonsillectomy

Procedure: Tonsillectomy; Device: HGNS

HGNS

ACTIVE COMPARATOR

HGNS alone (without concomitant tonsillectomy)

Device: HGNS

Interventions

HGNS DEVICE

HGNS alone (without concomitant tonsillectomy)

HGNS; HGNS plus tonsillectomy

Tonsillectomy PROCEDURE

Tonsillectomy

HGNS plus tonsillectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Massachusetts Eye and Ear Infirmary: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• Vena D, Op de Beeck S, Yang H, Sumner J, Mann D, Wang TY, Aishah A, Azarbarzin A, Messineo L, Calianese N, Alex R, Esmaeili N, Vanderveken OM, White DP, Wellman A, Huyett P, Sands SA. Lateral wall collapse from sleep endoscopy and airflow shape predicts hypoglossal nerve stimulation efficacy in obstructive sleep apnoea. Eur Respir J. 2025 Oct 7;66(4):2500236. doi: 10.1183/13993003.00236-2025. Print 2025 Oct.

  PMID: 40774807 BACKGROUND

• Huyett P, Kent DT, D'Agostino MA, Green KK, Soose RJ, Kaffenberger TM, Woodson BT, Huntley C, Boon MS, Heiser C, Birk A, Suurna MV, Lin HS, Waxman JA, Kezirian EJ. Drug-Induced Sleep Endoscopy and Hypoglossal Nerve Stimulation Outcomes: A Multicenter Cohort Study. Laryngoscope. 2021 Jul;131(7):1676-1682. doi: 10.1002/lary.29396. Epub 2021 Jan 14.

  PMID: 33443811 BACKGROUND

• Huyett P, Wellman A, Caruso V, Sumner J, Aishah A, Azarbarzin A, Sands S, Vena D. Combination Tonsillectomy and Hypoglossal Nerve Stimulation for Sleep Apnea Patients With Oropharyngeal Lateral Wall Collapse. Otolaryngol Head Neck Surg. 2024 Dec;171(6):1904-1910. doi: 10.1002/ohn.950. Epub 2024 Aug 27.

  PMID: 39189155 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Tonsillectomy

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Daniel Vena, PhD

CONTACT

16178520719; dvena@bwh.harvard.edu

Dillon Gilbertson, BASc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Harvard Medical School; Associate Scientist, Brigham and Women's Hospital

Model Details: This study is a prospective, parallel-group, randomized controlled trial evaluating whether concurrent tonsillectomy enhances the effectiveness of hypoglossal nerve stimulation (HGNS) in adults with obstructive sleep apnea and complete oropharyngeal lateral wall collapse. Participants will be randomized in a 1:1 ratio to receive either HGNS implantation with concurrent tonsillectomy (HGNS+T) or HGNS implantation alone. The primary analysis will compare clinical outcomes between the two randomized groups after approximately one month of optimized HGNS therapy.

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): February 1, 2031
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

US (1)