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

Обзор

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

Подробное описание

Obstructive sleep apnea (OSA) is commonly treated with hypoglossal nerve stimulation (HGNS), but treatment efficacy is substantially reduced in patients with complete oropharyngeal lateral wall (OPLW) collapse. HGNS primarily enlarges the airway by protruding the tongue and is therefore most effective in patients with anteroposterior patterns of airway collapse. Tonsillectomy reduces tissue contributing to lateral pharyngeal narrowing and may complement the mechanism of HGNS by addressing residual lateral wall obstruction. Preliminary clinical data suggest that combining tonsillectomy with HGNS substantially improves treatment response compared with HGNS alone in patients with OPLW collapse, but this strategy has not been evaluated in a randomized clinical trial.

This prospective, randomized controlled trial will enroll 72 adults with moderate-to-severe OSA, complete OPLW collapse identified on drug-induced sleep endoscopy, and candidacy for both HGNS implantation and tonsillectomy. Participants will be randomized 1:1 to receive either concurrent HGNS implantation plus tonsillectomy or HGNS implantation alone. All participants will undergo standard postoperative device activation and titration. The primary efficacy endpoint will be assessed after approximately one month of optimized HGNS therapy using sleep studies and patient-reported outcomes. Participants in the HGNS-alone group with persistent OSA may subsequently undergo delayed tonsillectomy as part of standard clinical care, permitting additional within-subject mechanistic comparisons.

The primary objective is to determine whether concurrent tonsillectomy improves the effectiveness of HGNS in reducing OSA severity compared with HGNS alone. Secondary objectives are to determine whether tonsillectomy enhances HGNS-induced improvements in upper-airway collapsibility and to evaluate whether tonsillectomy modifies the physiological effects of HGNS beyond the effects of either treatment alone. In an optional mechanistic substudy, approximately 30 participants will undergo detailed physiological sleep studies to measure pharyngeal collapsibility using gold-standard techniques, providing insight into the mechanisms underlying any observed improvement in clinical outcomes.

Вмешательства

• Процедура Tonsillectomy
  Tonsillectomy
• Устройство HGNS
  HGNS alone (without concomitant tonsillectomy)

Первичные конечные точки

• Percent reduction in apnea-hypopnea index (AHI) [Срок оценки: 1 month of optimized therapy.]

Вторичные конечные точки (3)

• Absolute change in apnea-hypopnea index [Срок оценки: 1 month of optimized therapy.]
• Treatment success [Срок оценки: 1 month of optimized therapy]
• Change in Sleep Apnea Hypoxic Burden from Baseline [Срок оценки: 1 month of optimized therapy]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Brigham and Women's Hospital — Boston

Публикации

• 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. Prin PMID 40774807
• 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
• 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

Идентификаторы

NCT: NCT07724938 · 2026P000343

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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