Characterize the Links Between Sleep, Emotional Dysregulation and Learning in Neurodevelopmental Disorders. (SOM-EMO-TND)

University Hospital, Strasbourg, France

Status

Not yet enrolling

Conditions

Attention Deficit Disorder With or Without Hyperactivity (ADHD)

Autism Spectrum Disorder (ASD)

Treatments

Behavioral: Trier Social Stress Task

Study type

Interventional

Funder types

Other

Identifiers

NCT06479668

9094

Details and patient eligibility

About

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).

Enrollment

40 estimated patients

Sex

All

Ages

7 to 12 years old

Volunteers

No Healthy Volunteers

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