[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639804":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":44,"studyPopulation":31,"armGroups":45,"interventions":57,"overallOfficials":65,"centralContacts":74,"locations":81,"responsibleParty":142,"collaborators":145,"id":151,"slug":31,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":152,"sex":158,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":31,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":171,"overallStatus":178,"whyStopped":31,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},{"fullName":5,"class":6},"Turku University Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Changes in AHI at baseline and after surgery","The primary outcome is changes in AHI measured with home sleep study","baseline, 4-6, 24 and 60 months after surgery.",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"Daytime sleepiness","Measured with Epworth Sleepiness Scale (ESS) questionnaire (patient-reported). Points 0-18, higher is worse.","Baseline and 6, 12, 24 and 60 months after surgery",{"measure":19,"description":20,"timeFrame":17},"Changes in insomnia symptoms","Measured with Insomnia Severity Index (ISI) questionnaire, points range 0-28, higher is worse.",{"measure":22,"description":23,"timeFrame":17},"Surgical success rate","Defined according to Sher's criteria: a reduction in AHI of \\>50% and a total AHI of \\\u003C20 after surgery",{"measure":25,"description":26,"timeFrame":17},"Surgical cure rate","Defined as a total AHI of \\\u003C5 after surgery",{"measure":28,"description":29,"timeFrame":30},"Changes in nocturnal desaturation","Changes in nocturnal desaturation measured with oxygen saturation (SaO2) mean, min, and SpO2 \\\u003C90% (T90) and ODI3, measured with home sleep study","Before surgery and 4-6, 24 and 60 months after surgery",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":35,"primaryPurpose":36,"observationalModel":31,"timePerspective":31,"maskingInfo":37},"RANDOMIZED","PARALLEL","Tonsil surgery is performed while patient is under general anesthesia by experienced otorhinolaryngologist who are familiar with both techniques (a minimum of 20 procedures performed using each technique).\n\nTT will be performed by removing approximately 60 - 90% of the tonsillar tissue, leaving a rim of tonsillar tissue on the tonsillar fossae. The tonsil capsule will not be breached.\n\nTE will be performed by dissection in the peritonsillar plane. Parts of the upper and lateral palatal mucosal arches will be incised, and an extracapsular dissection for complete tonsil excision will be performed.\n\nThe surgical instrumentation (eg. cold steel, monopolar diathermy with a pen electrode, bipolar scissors, coblation technique or a microdebrider) is selected by the surgeon.","TREATMENT",{"masking":38,"maskingDescription":39,"whoMasked":40},"TRIPLE","Due to the nature of surgical intervention, surgeon and care providers in the operation theatre are not blinded to treatment allocation. Trial participants, outcome assessors, and data analysts are blinded.",[41,42,43],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Adult reviews suggest tonsillotomy (TT) reduces morbidity compared to tonsillectomy (TE). In pediatric populations, the effectiveness of partial tonsil surgery for sleep apnea (OSA) is well-documented. It remains unclear if TT is non-inferior to TE in adults in the treatment of OSA. This study compares TE with TT in adults using change in apnea-hypopnea index as the primary endpoint.\n\nThe hypothesis is that TT is non-inferior compared to TE in treating patients with moderate or severe OSA and grade 2 to 4 tonsil size.\n\nParticipants are blinded to the allocated intervention with an allocation ratio 1:1. Participants will be recruited from patients referred to an outpatient hospital clinic. The trial will be carried out in four tertiary hospitals in Finland.",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"Tonsillectomy","ACTIVE_COMPARATOR","TE will be performed by dissection in the peritonsillar plane. Parts of the upper and lateral palatal mucosal arches will be incised, and an extracapsular dissection for complete tonsil excision will be performed.\n\nThe surgical instrumentation (eg. cold steel, monopolar diathermy with a pen electrode, bipolar scissors, coblation technique or a microdebrider) is selected by the surgeon.",[51],"Procedure: Tonsillectomy",{"label":53,"type":48,"description":54,"interventionNames":55},"Tonsillotomy","TT will be performed by removing approximately 60 - 90% of the tonsillar tissue, leaving a rim of tonsillar tissue on the tonsillar fossae. The tonsil capsule will not be breached.\n\nThe surgical instrumentation (eg. cold steel, monopolar diathermy with a pen electrode, bipolar scissors, coblation technique or a microdebrider) is selected by the surgeon.",[56],"Procedure: Tonsillotomy",[58,62],{"type":59,"name":47,"description":60,"armGroupLabels":61,"otherNames":31},"PROCEDURE","TE will be performed by dissection in the peritonsillar plane. Parts of the upper and lateral palatal mucosal arches will be incised, and an extracapsular dissection for complete tonsil excision will be performed.",[47],{"type":59,"name":53,"description":63,"armGroupLabels":64,"otherNames":31},"TT will be performed by removing approximately 60 - 90% of the tonsillar tissue, leaving a rim of tonsillar tissue on the tonsillar fossae. The tonsil capsule will not be breached.",[53],[66,69,72],{"name":67,"affiliation":5,"role":68},"Jaakko M Piitulainen, MD, PhD","STUDY_DIRECTOR",{"name":70,"affiliation":5,"role":71},"Henrik Sjöblom, MD","PRINCIPAL_INVESTIGATOR",{"name":73,"affiliation":5,"role":71},"Jenny Knubb, MD",[75,79],{"name":67,"role":76,"phone":77,"phoneExt":31,"email":78},"CONTACT","+35823130000","jaakko.piitulainen@utu.fi",{"name":70,"role":76,"phone":77,"phoneExt":31,"email":80},"henrik.sjoblom@varha.fi",[82,100,115,130],{"facility":83,"status":31,"city":84,"state":31,"zip":31,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"Helsinki University Hospital","Helsinki","Finland","FI",{"type":88,"coordinates":89},"Point",[90,91],24.93545,60.16952,{"lat":91,"lon":90},[94,98],{"name":95,"role":76,"phone":96,"phoneExt":31,"email":97},"Johanna Ruohoalho, MD, PhD","+35894711","firstname.lastname@hus.fi",{"name":99,"role":76,"phone":31,"phoneExt":31,"email":31},"Vanhapiha Nelli, MD",{"facility":101,"status":31,"city":102,"state":31,"zip":31,"country":85,"countryCode":86,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Oulu University Hospital","Oulu",{"type":88,"coordinates":104},[105,106],25.46816,65.01236,{"lat":106,"lon":105},[109,113],{"name":110,"role":76,"phone":111,"phoneExt":31,"email":112},"Aleksi Laajala, MD","+35886699500","firstname.lastname@oulu.fi",{"name":114,"role":76,"phone":31,"phoneExt":31,"email":31},"Alakärppä Antti, MD, PhD",{"facility":116,"status":31,"city":117,"state":31,"zip":31,"country":85,"countryCode":86,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Tampere University Hospital","Tampere",{"type":88,"coordinates":119},[120,121],23.78712,61.49911,{"lat":121,"lon":120},[124,128],{"name":125,"role":76,"phone":126,"phoneExt":31,"email":127},"Saara Markkanen, MD, PhD","+3583311611","firstname.lastname@pirha.fi",{"name":129,"role":76,"phone":31,"phoneExt":31,"email":31},"Saara Lesonen, MD",{"facility":5,"status":31,"city":131,"state":31,"zip":31,"country":85,"countryCode":86,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Turku",{"type":88,"coordinates":133},[134,135],22.26869,60.45148,{"lat":135,"lon":134},[138,141],{"name":139,"role":76,"phone":77,"phoneExt":31,"email":140},"Henrik M Sjöblom, MD","hmsjob@utu.fi",{"name":73,"role":76,"phone":77,"phoneExt":31,"email":31},{"type":71,"investigatorFullName":143,"investigatorTitle":144,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Jaakko Piitulainen","MD, PhD",[146,148,149],{"name":116,"class":147},"OTHER",{"name":101,"class":147},{"name":150,"class":147},"Helsinki University Central Hospital","100639804",false,"NCT07580170","Randomized Clinical Trial for Tonsil Surgery in Adults With Obstructive Sleep Apnea and Enlarged Tonsils","Multicenter, National, Randomized, Patient-Blinded, Parallel Group, Non-Inferiority Trial To Compare Tonsillotomy Versus Extracapsular Tonsillectomy in Adults With Obstructive Sleep Apnea and Tonsil Hypertrophy: The TONOS Trial.","TONOS","Inclusion Criteria:\n\n* BMI \\\u003C 35\n* Tonsil size 2 - 4\n* Otherwise healthy patient fit for tonsil surgery\n* Apnea-hypopnea index \\> 15\n* Obstructive sleep apnea symptoms\n\nExclusion Criteria:\n\n* Pathological hemostasis or use of anticoagulation\n* Craniofacial deformities\n* Neurological condition with muscular hypotonia\n* Other surgical treatment for OSA","ALL","18 Years","65 Years",{"count":162,"type":163},132,"ESTIMATED","INTERVENTIONAL",[166],"NA","The aim is to investigate whether the tissue-preserving tonsil surgery technique is as effective as complete tonsil removal in the treatment of obstructive sleep apnea. The primary outcome measure is the change in the apnea-hypopnea index (AHI) before surgery and at 4-6, 24, and 60 months after surgery.",[169,170],"Sleep Apnea, Obstructives","Tonsil Hypertrophy",[172,173,174,175,176,177],"sleep apnea","tonsillectomy","tonsillotomy","intracapsular tonsillectomy","adults","tonsil hypertrophy","NOT_YET_RECRUITING","2026-05-31",{"date":181,"type":182},"2026-06-03","ACTUAL",{"date":184,"type":163},"2026-10-01",{"date":186,"type":163},"2036-01-01",{"name":5,"class":6},4]