Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT06479668
Eligibility Criteria:
Inclusion Criteria:
* Subjects aged 7 to 12
* Able to receive clear, age-appropriate information and to participate fully in the study
* Whose legal representative(s) are able to understand the objectives and risks of the research and to give their dated and signed informed consent.
* Subjects benefiting from a social health insurance plan (beneficiary of the legal representative(s))
* 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).
* 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
* No diagnosis of: fragile X syndrome, Rett syndrome, trisomy 21, tuberous sclerosis of Bourneville, von Recklinghausen disease, Cytomegalovirus encephalitis (CMV encephalitis), congenital rubella, phenylketonuria
* No clinically significant abnormality which, in the investigator's opinion, could interfere with the implementation of the study.
Exclusion Criteria:
\- 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, ...).
tumor, ...)
* Transmeridian travel (\> 2 time zones) in the month prior to study inclusion
* Presence of a mood disorder (bipolar disorder or depression) according to DSM-5 criteria
* Social jet-lag \> 2 hours (mid-point of sleep differential during weekends vs. weekdays)
* Modification of psychotropic medication in the 2 months prior to inclusion
* Use of melatonin-based dietary supplement(s)/medication(s) in the 24 hours prior to study inclusion
* Use of psychostimulant(s) within 48 hours of study entry
* Extreme chronotype (Morningness/Eveningness questionnaire score \< 10 or \> 42)
* Cognitive-behavioral therapies (CBT) targeting sleep disorders
* Participation in research involving an experimental drug which may interfere with the protocol\*.
* Minor under guardianship
* Subject in a period of exclusion (determined by a previous or current study)
* Subject in emergency situation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
12 Years
Study:
NCT06479668
Study Brief:
Protocol Section:
NCT06479668