Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
Study NCT ID:
NCT04314492
Status:
COMPLETED
Last Update Posted:
2025-04-25
First Post:
2020-03-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014068', 'term': 'Tonsillectomy'}], 'ancestors': [{'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2020-03-13', 'studyFirstSubmitQcDate': '2020-03-17', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Apnea-hypopnea index', 'timeFrame': '24 months', 'description': 'Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography.'}, {'measure': 'Apnea-hypopnea index', 'timeFrame': '60 months', 'description': 'Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography.'}], 'primaryOutcomes': [{'measure': 'Apnea-hypopnea index', 'timeFrame': '6 months', 'description': 'Post-operative apnea-hypopnea index reduction by 50% compared to preoperative values in polysomnography.'}], 'secondaryOutcomes': [{'measure': 'Quality of life measured by Glasgow Benefit Inventory', 'timeFrame': '6 months and 24 month and 60 months', 'description': 'General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better.'}, {'measure': 'Quality of life measured by Nordic tonsil surgery register questionnaire', 'timeFrame': '6 months - up to 5 years', 'description': 'Questions regarding postoperative complications and perceived symptom relief after 180 days. Yes/no questions and open questions, no score.'}, {'measure': 'Quality of life measured by Epworth sleepiness scale', 'timeFrame': '6 months - up to 5 years', 'description': 'Questions regarding sleepiness. Score 0-24, lower is better.'}, {'measure': 'Post-operative recovery', 'timeFrame': '21 days', 'description': 'Recovery speed defined as score 3 or less at rest; or 5 or less without regular analgesics use, questionnaire used: Brief Pain Inventory.'}, {'measure': 'Total recovery of obstructive sleep apnea', 'timeFrame': '6 months and 24 months and 60 months', 'description': 'Defined by apnea-hypopnea index \\<5 post-operatively in polysomnography.'}, {'measure': 'Regrowth of tonsillar tissue', 'timeFrame': 'Pre-operative to 6 months', 'description': 'Measured by photography, Friedman scale (0-4, lower is smaller).'}, {'measure': 'Apnea-index', 'timeFrame': '6 months and 24 months and 60 months', 'description': 'Post-operative apnea index reduction by 50% compared to preoperative values in polysomnography.'}, {'measure': 'Snoring time', 'timeFrame': '6 months and 24 months and 60 months', 'description': 'Post-operative reduction of snoring time in preoperative polysomnography compared to post-operative values in'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tonsil surgery', 'tonsillectomy', 'obstructive sleep apnea', 'coblation', 'intracapsular'], 'conditions': ['Tonsillar Hypertrophy', 'Sleep Apnea, Obstructive']}, 'descriptionModule': {'briefSummary': 'Treating sleep apnea in adults caused by tonsillar hypertrophy with intracapsular tonsillectomy by coblation', 'detailedDescription': 'The investigators aim to study if good surgical results can be achieved by intracapsular tonsillectomy with coblation while monitoring safety, efficiency and cost-effectiveness. In adult tonsil surgery, the current practice in Finland is commonly extracapsular tonsillectomy with monopolar electrosurgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 16-64\n* Planned tonsil surgery with informed concent\n* Obstructive sleep apnea (AHI \\> 15)\n* Tonsillar size of 3-4 on the Friedman scale\n\nExclusion Criteria:\n\n* BMI \\> 35 (Based on finnish Käypä Hoito -recommendations)\n* Central sleep apnea\n* Weight loss of more than 10% within the study period\n* Untreated obstruction of nasal breathing\n* Treated peritonsillar abscess \\<1 month before enrollment\n* Active tonsillar infection\n* Previous tonsillar surgery (excluding incision of abscess)\n* Malignancy\n* High use of analgesics \\>1 DDD daily during last 4 weeks\n* Untreated reflux\n* Anticoagulative medication\n* Any condition of hemophilia\n* Pregnancy, lactation\n* Other, evaluated by treating physician'}, 'identificationModule': {'nctId': 'NCT04314492', 'briefTitle': 'Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults', 'orgStudyIdInfo': {'id': 'T62/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intracapsular tonsillectomy with coblation', 'description': '(Total) Intracapsular tonsillectomy (ICTE) with coblation', 'interventionNames': ['Procedure: Tonsillectomy']}], 'interventions': [{'name': 'Tonsillectomy', 'type': 'PROCEDURE', 'description': 'Intracapsular removal of tonsillar tissue (\\>90%) with coblation', 'armGroupLabels': ['Intracapsular tonsillectomy with coblation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28500', 'city': 'Pori', 'state': 'Satakunta', 'country': 'Finland', 'facility': 'Satasairaala', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}, {'zip': '20521', 'city': 'Turku', 'state': 'Southwest Finland', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Jussi Jero, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Turku'}, {'name': 'Jaakko Piitulainen, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, Doctor of Medical Science', 'investigatorFullName': 'Jaakko Piitulainen', 'investigatorAffiliation': 'Turku University Hospital'}}}}