Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2026-04-13 @ 9:29 PM
Study NCT ID:
NCT02477735
Status:
UNKNOWN
Last Update Posted:
2015-06-23
First Post:
2015-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Tympanostomy Tube Insertion on Sleep in Children With Chronic Otitis Media With Effusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D056044', 'term': 'Actigraphy'}], 'ancestors': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D061725', 'term': 'Accelerometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-17', 'studyFirstSubmitDate': '2015-05-21', 'studyFirstSubmitQcDate': '2015-06-17', 'lastUpdatePostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Actigraphy measurements', 'timeFrame': 'Up to two years'}], 'secondaryOutcomes': [{'measure': 'OSA-18 questionnaire score', 'timeFrame': 'Up to two years'}, {'measure': 'Brief Infant Sleep Questionnaire (BISQ) score', 'timeFrame': 'Up to two years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Otitis Media With Effusion', 'Sleep Disturbances']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the prevalence of sleep disturbances in children with Chronic Otitis Media with Effusion (COME) and the effect of tympanostomy tube insertion (TTI) on sleep disturbances.', 'detailedDescription': "Comparison of sleep disturbances will be between infants with Chronic Otitis Media with Effusion (COME) who will be referred for tympanostomy tube insertion (TTI) (study group) and healthy infants that were recruited from the community well-baby clinics (control group).\n\nTo evaluate sleep patterns, parents of the study group will complete two validated sleep questionnaires assessing the infant's typical sleep patterns based on parental reports. A week before TTI and 1 week to 1 month after the surgery, sleep will be evaluate by actigraph for a week long."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants with COME who will be referred for TTI.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 6-36 months\n* Referred for tympanostomy tube insertion as a treatment for COME.\n\nExclusion Criteria:\n\n* Snoring and sleep disordered breathing (SDB)\n* Chronic medical condition\n* referred for TTI and adenoidectomy/tonsillectomy'}, 'identificationModule': {'nctId': 'NCT02477735', 'briefTitle': 'The Effect of Tympanostomy Tube Insertion on Sleep in Children With Chronic Otitis Media With Effusion', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'The Effect of Tympanostomy Tube Insertion on Sleep in Children With Chronic Otitis Media With Effusion', 'orgStudyIdInfo': {'id': 'TASMC-15-GF-0021-15-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Infants with COME who will be referred for TTI will undergo actigraphy for 7 consecutive nights prior to TTI and for 7 consecutive nights 4-6 weeks following TTI.', 'interventionNames': ['Device: Actigraphy']}, {'label': 'Healthy infants', 'description': 'Healthy infants that were recruited from the community well-baby clinics.'}], 'interventions': [{'name': 'Actigraphy', 'type': 'DEVICE', 'description': 'Actigraphy will be conducted for each participant for 7 consecutive nights prior to TTI and for 7 consecutive nights 4-6 weeks following TTI.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': '"DANA" children\'s hospital', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Gad Fishman, Doctor', 'role': 'CONTACT', 'email': 'gadf@tlvmc.gov.il', 'phone': '+972-2-4266362'}], 'overallOfficials': [{'name': 'Gad Fishman, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Dana Children's Hospital, Tel-Aviv Sourasky Medical Center, Sackler School of Medicine Tel-Aviv Univesity, Israel"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}