Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-03-02 @ 5:33 PM
Study NCT ID:
NCT04197518
Status:
UNKNOWN
Last Update Posted:
2019-12-13
First Post:
2019-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-11', 'studyFirstSubmitDate': '2019-12-11', 'studyFirstSubmitQcDate': '2019-12-11', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurocognitive Functions Among Children', 'timeFrame': '2 years', 'description': 'neurology test using neuro trax system , to evaluate Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Child Neurocognitive Function']}, 'descriptionModule': {'briefSummary': 'Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children between 6-18 years old.\n* children with enlarged tonsils or adenoids.\n* a sleep lab test before the procedure.\n\nExclusion Criteria:\n\n* children under 6 years old and above 18 years old.\n* patience that treated in ADHD / ADDOR with other neurocognitive disorder.'}, 'identificationModule': {'nctId': 'NCT04197518', 'briefTitle': 'Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy', 'orgStudyIdInfo': {'id': '0042-18-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Children With Enlargement Adenoid and Tonsils', 'description': 'Children With Enlargement Adenoid and Tonsils', 'interventionNames': ['Diagnostic Test: neuro trax system and a neurology test.']}], 'interventions': [{'name': 'neuro trax system and a neurology test.', 'type': 'DIAGNOSTIC_TEST', 'description': 'the neurology will check the patience before and after tonsillectomy or adenotonsillectomy usung the neurotrax system, these parameters will be measured in this system : Non verbal memory, Go no go test, stroop interference, Visual spatial processing, Staged information processing speed, "catch" game, problem solving.', 'armGroupLabels': ['Children With Enlargement Adenoid and Tonsils']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}