[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07724938":3,"trial-entities:NCT07724938":113,"trial-summary:NCT07724938":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":46,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":78,"locations":81,"central_contacts":90,"overall_officials":100,"references":101,"see_also_links":112},"NCT07724938","2026P000343","Combination Tonsillectomy and Hypoglossal Nerve Stimulation for OSA Patients With Lateral Pharyngeal Collapse","NOT_YET_RECRUITING","2031-02","2026-07","2026-07-24","2026-08","Brigham and Women's Hospital","OTHER",true,"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:\n\n1. Does hypoglossal nerve stimulation combined with tonsillectomy reduce the severity of obstructive sleep apnea more than hypoglossal nerve stimulation alone?\n2. Does tonsillectomy improve how effectively hypoglossal nerve stimulation opens and stabilizes the upper airway?\n\nResearchers will compare participants who receive hypoglossal nerve stimulation with tonsillectomy to participants who receive hypoglossal nerve stimulation alone.\n\nParticipants will:\n\n* Complete sleep studies, questionnaires, and other assessments before and after treatment\n* Be randomly assigned to receive hypoglossal nerve stimulation either with or without tonsillectomy\n* Return for follow-up visits and sleep testing to evaluate treatment effectiveness\n* In a subset of participants, complete additional overnight testing to measure how treatment changes upper-airway collapsibility","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.\n\nThis 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.\n\nThe 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.",[18,19],"Obstructive Sleep Apnea","Sleep Disordered Breathing",[21,22,23],"Obstructive sleep apnea","Hypoglossal nerve stimulation","Tonsillectomy","INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},72,"ESTIMATED",[32,36],{"type":33,"name":23,"description":23,"armGroupLabels":34},"PROCEDURE",[35],"HGNS plus tonsillectomy",{"type":37,"name":38,"description":39,"armGroupLabels":40},"DEVICE","HGNS","HGNS alone (without concomitant tonsillectomy)",[38,35],[42],{"measure":43,"description":44,"timeFrame":45},"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.",[47,50,54],{"measure":48,"description":49,"timeFrame":45},"Absolute change in apnea-hypopnea index","Absolute change in the apnea-hypopnea index (AHI), measured in events per hour by overnight polysomnography, from baseline to the primary follow-up sleep study. Negative values indicate improvement in obstructive sleep apnea.",{"measure":51,"description":52,"timeFrame":53},"Treatment success","Treatment success is defined as a ≥50% reduction in the apnea-hypopnea index (AHI) from baseline and a follow-up AHI \\\u003C15 events per hour. The outcome is reported as the proportion of participants meeting this definition (0-100%), with higher values indicating greater treatment success.","1 month of optimized therapy",{"measure":55,"description":56,"timeFrame":53},"Change in Sleep Apnea Hypoxic Burden from Baseline","Sleep apnea hypoxic burden will be calculated from overnight polysomnography using the validated Azarbarzin method (PMID: 30376054) as the cumulative area under the oxygen desaturation curve associated with apneas and hypopneas, normalized to total sleep time and expressed as %min\u002Fhour. Higher values indicate greater hypoxic burden.","ALL","18 Years",null,false,{"inclusion":62,"exclusion":70,"raw_text":77},[63,64,65,66,67,68,69],"Age ≥ 18 years","Diagnosis of obstructive sleep apnea with apnea-hypopnea index (AHI) ≥ 15 events\u002Fhour","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",[71,72,73,74,75,76],"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","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of obstructive sleep apnea with apnea-hypopnea index (AHI) ≥ 15 events\u002Fhour\n* Complete oropharyngeal lateral wall (OPLW) collapse identified on DISE\n* Candidate for HGNS implantation based on standard clinical criteria\n* Presence of small (1-2+) tonsils and eligibility for tonsillectomy\n* Untreated OSA at the time of enrollment\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Absence of tonsils\n* Presence of large tonsils (3-4+; not eligible for HGNS)\n* Predominant central or mixed sleep apnea (\\>25% central or mixed events)\n* Any unstable or serious medical condition that, in the opinion of the investigator, would increase risk or interfere with study participation\n* Ineligibility for HGNS implantation based on standard clinical or surgical criteria\n* Inability to comply with study procedures or follow-up assessments",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":12,"city":83,"state":84,"zip":85,"country":86,"geoPoint":87},"Boston","Massachusetts","02115","United States",{"lat":88,"lon":89},42.35843,-71.05977,[91,96],{"name":92,"role":93,"phone":94,"email":95},"Daniel Vena, PhD","CONTACT","16178520719","dvena@bwh.harvard.edu",{"name":97,"role":93,"phone":98,"email":99},"Dillon Gilbertson, BASc","617-732-6488","dgilbertson@bwh.harvard.edu",[],[102,106,109],{"pmid":103,"type":104,"citation":105},"40774807","BACKGROUND","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\u002F13993003.00236-2025. Print 2025 Oct.",{"pmid":107,"type":104,"citation":108},"33443811","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\u002Flary.29396. Epub 2021 Jan 14.",{"pmid":110,"type":104,"citation":111},"39189155","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\u002Fohn.950. Epub 2024 Aug 27.",[],{"nct_id":4,"conditions":114,"biomarkers":115},[18],[],{"nct_id":4,"found":14,"summary":117,"prompt_version":127},{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is a randomized controlled trial involving 72 participants. You would be randomly assigned to receive either HGNS with tonsillectomy or HGNS alone.","completed","Tonsillectomy and Hypoglossal Nerve Stimulation for Sleep Apnea","This study is looking at adults with obstructive sleep apnea (OSA) where the side walls of their throat collapse during sleep. Researchers want to see if removing the tonsils at the same time as getting a hypoglossal nerve stimulation (HGNS) device helps more than just getting the HGNS device alone. HGNS is a device that helps open your airway by moving your tongue forward. The study aims to find out if combining tonsillectomy with HGNS reduces sleep apnea more effectively and improves how well HGNS works. You might be able to join if you are 18 or older, have moderate to severe OSA, and are a candidate for both HGNS and tonsillectomy. The main goal is to see how much your apnea-hypopnea index (AHI) improves after about one month of treatment.","Your primary outcome will be measured after approximately one month of optimized therapy.",131,"You would undergo either HGNS implantation with tonsillectomy or HGNS implantation alone. After surgery, you would have standard device activation and adjustments, with an assessment after about one month of optimized therapy.","Not stated in the trial record.",[23,38],"v2"]