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NCT Number: NCT06479668

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

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trier Social Stress Task

Behavioral

Specify details not covered in associated Arm Description.

Primary outcomes

  1. change micro-awakening index

    Time frame: At Day 0 and Day 3

    polysomnography

Study contacts

Contact information is provided by the study sponsor or research team.

Carmen Schroder, MD

CONTACT

[email protected]

0033388116218

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: SOM-EMO-TND

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 28, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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