Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-02-28 @ 9:04 PM
Study NCT ID:
NCT02233166
Status:
UNKNOWN
Last Update Posted:
2017-08-23
First Post:
2014-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OSA in Children Referred for Adenotonsillectomy
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-22', 'studyFirstSubmitDate': '2014-08-13', 'studyFirstSubmitQcDate': '2014-09-05', 'lastUpdatePostDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'Up to 2 years', 'description': 'Questionnaire'}, {'measure': 'Risk factors of OSA', 'timeFrame': 'Up to 2 years', 'description': 'Questionnaire'}, {'measure': 'Post operative complications', 'timeFrame': 'Up to 2 years', 'description': 'Questionnaire; pulse oximetry'}], 'primaryOutcomes': [{'measure': 'Prevalence of OSA', 'timeFrame': 'Up to 2 years', 'description': 'Apne hypopne index (AHI)/ respiratory disturbance index (RDI)'}], 'secondaryOutcomes': [{'measure': 'Post operative PSG results', 'timeFrame': 'Up to 2 years', 'description': 'Apne hypopne index (AHI)/ respiratory disturbance index (RDI)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '32402922', 'type': 'DERIVED', 'citation': 'Overland B, Berdal H, Akre H. Correlations between disease-specific quality of life and polysomnographic findings in children with obstructive sleep apnea. Int J Pediatr Otorhinolaryngol. 2020 Jul;134:110077. doi: 10.1016/j.ijporl.2020.110077. Epub 2020 Apr 30.'}]}, 'descriptionModule': {'briefSummary': 'In children with OSA (Obstructive sleep apnea) adenotonsillectomy is regarded as the first choice of treatment. Studies in recent years have shown that the procedure does not always have the expected effect. Children with OSA are at greater risk for complications from the procedure.\n\nThere is disagreement regarding the need for sleep studies in children prior to surgery in order to verify an OSA diagnosis. Today less than 10% of these children have polysomnography (PSG).\n\nThe main purpose of this study is to describe the prevalence of OSA among children referred for adenotonsillectomy.\n\nThe investigators will also examine these children prior to and six months after surgery to assess their sleep pattern and quality of life.\n\nThe project outcome aims to improve the precision and quality of diagnosis and the short and long term effects of treatment of children with OSA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged between 2 and 5 years who are referred for adenoidectomy and/or tonsillectomy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 2-5 year\n* referred for adenoidectomy and/or tonsillectomy\n\nExclusion Criteria:\n\n* craniofacial anomalies\n* neurological diseases\n* neuropsychiatric diseases'}, 'identificationModule': {'nctId': 'NCT02233166', 'briefTitle': 'OSA in Children Referred for Adenotonsillectomy', 'organization': {'class': 'OTHER', 'fullName': 'Lovisenberg Diakonale Hospital'}, 'officialTitle': 'Obstructive Sleep Apnea in Children Referred for Adenotonsillectomy', 'orgStudyIdInfo': {'id': '2012/1117'}}, 'contactsLocationsModule': {'locations': [{'zip': '0456', 'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Britt Øverland, PhD', 'role': 'CONTACT', 'email': 'brov@lds.no', 'phone': '+4723226326'}, {'name': 'Hanne Berdal, MD', 'role': 'CONTACT', 'email': 'habs@lds.no', 'phone': '+4723226381'}, {'name': 'Britt Øverland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lovisenberg Diakonale Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lovisenberg Diakonale Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}