Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-26 @ 4:47 AM
Study NCT ID:
NCT06661759
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-04
First Post:
2024-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-10-24', 'studyFirstSubmitQcDate': '2024-10-24', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective sleep parameter by actigraphy', 'timeFrame': 'Baseline, 3 , 6 , and 12 months after randomization', 'description': "Actigraphy is an objective sleep measurement method that assesses physical motion through a small device worn on the non-dominant wrist. Children's sleep will be objectively assessed for 7 days using actigraphy at each assessment time point. The monitor is a wristwatch-like device with an accelerometer sensitive to body movement. Detected physical motion will be stored as activity counts at 30-second intervals and converted to sleep parameters. Outcome measures derived from actigraphy will include:\n\n1. sleep quantity variables as measured by durations of nighttime, daytime, and total 24 hour sleep.\n2. sleep quality variable as measured by sleep efficiency."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'Sleep problems are more common and more severe in children with epilepsy. The purpose of this study is to develop and evaluate the effect of a clinic-based and technology-supported sleep intervention for improving sleep and health in children with epilepsy and their parents.', 'detailedDescription': 'Participants in the intervention group will receive a standard pediatric neurology care plus a hybrid in-person and digital sleep education program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged between 1.5 and 9 years with a confirmed diagnosis of epilepsy.\n* Parents with sufficient Chinese language skills to fully comprehend the trial and complete questionnaires.\n\nExclusion Criteria:\n\n* Children with cerebral palsy or those who are bedridden.\n* Children with a documented sleep disorder, such as obstructive or central sleep apnea and sleep-related movement disorders\n* Children born with a congenital, genetic, or orthopedic abnormality that limit their activities of daily living or impair their physical activity.'}, 'identificationModule': {'nctId': 'NCT06661759', 'briefTitle': 'Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy', 'orgStudyIdInfo': {'id': '202402064RINE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental intervention group', 'description': 'standard pediatric neurology care plus a hybrid in-person and digital sleep education program', 'interventionNames': ['Behavioral: Clinic-based and technology-supported sleep intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care group', 'description': 'standard pediatric neurology care'}], 'interventions': [{'name': 'Clinic-based and technology-supported sleep intervention', 'type': 'BEHAVIORAL', 'description': "CATS sleep intervention: The in-person sleep education and consultation will consist of 3 face-to-face, one-on-one sessions held 3 months apart during the child's routine clinic visit.The digital component of the sleep intervention will extend in-person education by providing ongoing support. Participants will receive one digital session per week for four weeks after the baseline, 3-month, and 6-month clinic visits, totaling 12 sessions.", 'armGroupLabels': ['Experimental intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'contacts': [{'name': 'Yi-Shan Sung', 'role': 'CONTACT', 'email': 'yshansung33@ntu.edu.tw', 'phone': '+88623123456', 'phoneExt': '288904'}, {'name': 'Shao-Yu Tsai', 'role': 'CONTACT', 'email': 'stsai@ntu.edu.tw', 'phone': '+88623123456', 'phoneExt': '262962'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yi-Shan Sung', 'role': 'CONTACT', 'email': 'yshansung33@ntu.edu.tw', 'phone': '+886223123456', 'phoneExt': '288904'}, {'name': 'Shao-Yu Tsai', 'role': 'CONTACT', 'email': 'stsai@ntu.edu.tw', 'phone': '+886223123456', 'phoneExt': '262962'}], 'overallOfficials': [{'name': 'Shao-Yu Tsai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}