Menu
Not yet recruiting NCT06479668

Characterize the Links Between Sleep, Emotional Dysregulation and Learning in Neurodevelopmental Disorders.

No phase Interventional Attention Deficit Disorder With or Without Hyperactivity (ADHD) Autism Spectrum Disorder (ASD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trier Social Stress Task.
Who it may be relevant to
Registry conditions: Attention Deficit Disorder With or Without Hyperactivity (ADHD), Autism Spectrum Disorder (ASD). Basic parameters: 7 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Behavioral Trier Social Stress Task
    Specify details not covered in associated Arm Description.

Primary outcome measures

  • change micro-awakening index [Time frame: At Day 0 and Day 3]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06479668 · 9094

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗