Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-27 @ 3:52 PM
Study NCT ID:
NCT06479668
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-15
First Post:
2024-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterize the Links Between Sleep, Emotional Dysregulation and Learning in Neurodevelopmental Disorders.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2024-06-21', 'studyFirstSubmitQcDate': '2024-06-27', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change micro-awakening index', 'timeFrame': 'At Day 0 and Day 3', 'description': 'polysomnography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Attention Deficit Disorder With or Without Hyperactivity (ADHD)', 'Autism Spectrum Disorder (ASD)']}, 'descriptionModule': {'briefSummary': "The aim of this protocol is to disentangle the links between symptoms of emotion dysregulation, sleep disorders and cognitive deficits by measuring the effects of an emotional induction task on childrens' sleep with autism spectrum disorders (ASD) and attention deficit hyperactivity disorder (ADHD)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects aged 7 to 12\n* Able to receive clear, age-appropriate information and to participate fully in the study\n* Whose legal representative(s) are able to understand the objectives and risks of the research and to give their dated and signed informed consent.\n* Subjects benefiting from a social health insurance plan (beneficiary of the legal representative(s))\n* With a diagnosis made prior to inclusion of Autism Spectrum Disorder (ASD) or Attention Deficit Disorder with or without Hyperactivity (ADHD) as defined by Diagnostic and Statistical Manual 5 (DSM-5).\n* With abbreviated intelligence quotient \\> 80 measured by Wechsler Intelligence Scale for Children version IV (WISC-IV )no more than 6 months prior to research inclusion\n* No diagnosis of: fragile X syndrome, Rett syndrome, trisomy 21, tuberous sclerosis of Bourneville, von Recklinghausen disease, Cytomegalovirus encephalitis (CMV encephalitis), congenital rubella, phenylketonuria\n* No clinically significant abnormality which, in the investigator's opinion, could interfere with the implementation of the study.\n\nExclusion Criteria:\n\n\\- Current or past neurological problem(s) (e.g. stroke, epilepsy, meningitis, head trauma with loss of consciousness of more than 15 min, concussion, brain tumor, ...).\n\ntumor, ...)\n\n* Transmeridian travel (\\> 2 time zones) in the month prior to study inclusion\n* Presence of a mood disorder (bipolar disorder or depression) according to DSM-5 criteria\n* Social jet-lag \\> 2 hours (mid-point of sleep differential during weekends vs. weekdays)\n* Modification of psychotropic medication in the 2 months prior to inclusion\n* Use of melatonin-based dietary supplement(s)/medication(s) in the 24 hours prior to study inclusion\n* Use of psychostimulant(s) within 48 hours of study entry\n* Extreme chronotype (Morningness/Eveningness questionnaire score \\< 10 or \\> 42)\n* Cognitive-behavioral therapies (CBT) targeting sleep disorders\n* Participation in research involving an experimental drug which may interfere with the protocol\\*.\n* Minor under guardianship\n* Subject in a period of exclusion (determined by a previous or current study)\n* Subject in emergency situation"}, 'identificationModule': {'nctId': 'NCT06479668', 'acronym': 'SOM-EMO-TND', 'briefTitle': 'Characterize the Links Between Sleep, Emotional Dysregulation and Learning in Neurodevelopmental Disorders.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Characterize the Links Between Sleep, Emotional Dysregulation and Learning in Neurodevelopmental Disorders.', 'orgStudyIdInfo': {'id': '9094'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autism Spectrum Disorder', 'interventionNames': ['Behavioral: Trier Social Stress Task']}, {'type': 'EXPERIMENTAL', 'label': 'Attention Deficit Disorder with or without Hyperactivity', 'interventionNames': ['Behavioral: Trier Social Stress Task']}], 'interventions': [{'name': 'Trier Social Stress Task', 'type': 'BEHAVIORAL', 'description': 'Specify details not covered in associated Arm Description.', 'armGroupLabels': ['Attention Deficit Disorder with or without Hyperactivity', 'Autism Spectrum Disorder']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Carmen Schroder, MD', 'role': 'CONTACT', 'email': 'carmen.schroder@chru-strasbourg.fr', 'phone': '0033388116218'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}