Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-30 @ 7:55 AM
Study NCT ID:
NCT05049369
Status:
COMPLETED
Last Update Posted:
2023-12-26
First Post:
2021-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Results of 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'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'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': 'D017286', 'term': 'Polysomnography'}], 'ancestors': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-22', 'studyFirstSubmitDate': '2021-09-10', 'studyFirstSubmitQcDate': '2021-09-10', 'lastUpdatePostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea-hypopnea index', 'timeFrame': '3-17 years', 'description': 'Post-operative apnea-hypopnea index (AHI) reduction by 50% compared to preoperative values in polysomnography.'}], 'secondaryOutcomes': [{'measure': 'Quality of life measured by Glasgow Benefit Inventory (GBI)', 'timeFrame': '3-17 years', 'description': 'General quality of life questionnaire. 18 questions, score 1-5 in each question, higher is better.'}, {'measure': 'Quality of life measured by Epworth sleepiness scale (ESS)', 'timeFrame': '3-17 years', 'description': 'Questions regarding sleepiness. Score 0-24, lower is better.'}, {'measure': 'Apnea-index (AI)', 'timeFrame': '3-17 years', 'description': 'Post-operative apnea index reduction compared to preoperative values in polysomnography.'}, {'measure': 'Snoring time', 'timeFrame': '3-17 years', 'description': 'Post-operative reduction of snoring time compared to preoperative values in polysomnography'}, {'measure': 'Oxygen Desaturation Index (ODI)', 'timeFrame': '3-17 years', 'description': 'Post-operative reduction of oxygen desaturation index compared to preoperative values in polysomnography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tonsillectomy', 'obstructive sleep apnea', 'tonsil surgery'], 'conditions': ['Obstructive Sleep Apnea', 'Tonsillar Hypertrophy', 'Sleep Apnea Syndromes']}, 'descriptionModule': {'briefSummary': 'Long-term results of tonsillectomy in the treatment of obstructive sleep apnea in adults', 'detailedDescription': 'The investigators are studying long-term efficiency of tonsillectomy in adults with obstructive sleep apnea caused by tonsillar hypertrophy. These patients have undergone tonsillectomy in 2004-2018 and now 3-17 years later investigators will perform new polysomnographies and compare these results with preoperative values. Especially the reduction in apnea-hypopnea index (AHI) will be evaluated. The quality of life and possible symptoms will be measured with questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age at least 16 during tonsillectomy\n* preoperative obstructive sleep apnea and AHI (apnea-hypopnea index) \\> 14\n* tonsillectomy has been done because of the symptoms caused by tonsillar hypertrophy (ICD-10 diagnostic codes G47.3, R06.5 or J35.1)\n* in addition to tonsillectomy, patients may have undergone shortening of uvula and/or radio frequency ablation of soft palate\n\nExclusion Criteria:\n\n* AHI \\< 14\n* in addition to tonsillectomy patient has undergone uvulectomy, uvulopalatoplasty, uvulopalatopharyngoplasty or mandibular advancement\n* other, evaluated by investigator'}, 'identificationModule': {'nctId': 'NCT05049369', 'briefTitle': 'Long-term Results of Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Long-term Results of Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults', 'orgStudyIdInfo': {'id': 'T205/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Polysomnography for all participants of the study', 'description': 'Polysomnography device is used to measure certain variables overnight when a participant is sleeping', 'interventionNames': ['Device: Polysomnography']}], 'interventions': [{'name': 'Polysomnography', 'type': 'DEVICE', 'description': 'Polysomnography is performed one time overnight', 'armGroupLabels': ['Polysomnography for all participants of the study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20521', 'city': 'Turku', 'state': 'Southwest Finland', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Jaakko M Piitulainen, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Otorhinolaryngology, Turku University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}