Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-01 @ 4:52 PM
Study NCT ID:
NCT07023458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-04
First Post:
2025-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Hypoxic Burden on Executive Function (EF) in Preschool Children With Obstructive Sleep Apnea
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-06-07', 'studyFirstSubmitQcDate': '2025-06-07', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Executive function from BRIEF-P test', 'timeFrame': '3 months', 'description': 'T-scores at or below 59 are considered to be within the typical range'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea (OSA)']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to study the effect of hypoxic burden on executive function in preschool children aged 2-6 years who have OSA.\n\nThe main question it aims to answer is Effect of hypoxic burden from OSA to executive function measured by BRIEF-P in preschool children..', 'detailedDescription': 'There is no comparison group in this study Participants will performed full night polysomnography, Denver and BRIEF-P test within 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Siriraj Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 2-6 years old with OSA\n\nExclusion Criteria:\n\n* Underlying diseases : hypoventilation, neuromuscular diseases, etc.'}, 'identificationModule': {'nctId': 'NCT07023458', 'briefTitle': 'The Effects of Hypoxic Burden on Executive Function (EF) in Preschool Children With Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'The Effects of Hypoxic Burden on Executive Function (EF) in Preschool Children With Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'COA119/2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'All participants in the group will undergo polysomnography, Denver test and BRIEF-P test for executive function', 'interventionNames': ['Diagnostic Test: Brief-P']}], 'interventions': [{'name': 'Brief-P', 'type': 'DIAGNOSTIC_TEST', 'description': 'Executive function test in preschool children with OSA', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok Noi', 'state': 'Bangkok', 'country': 'Thailand', 'contacts': [{'name': 'Sarisa Thawongit', 'role': 'CONTACT', 'email': 'sarisa.thw@mahidol.ac.th', 'phone': '66-241-97536'}], 'facility': 'Siriraj Hospital', 'geoPoint': {'lat': 13.76266, 'lon': 100.47798}}], 'centralContacts': [{'name': 'Sarisa Thawongit, Pediatric sleep medicine', 'role': 'CONTACT', 'email': 'sarisa.thw@mahidol.ac.th', 'phone': '668-654-00288'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sarisa Thawongit', 'investigatorAffiliation': 'Mahidol University'}}}}