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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorUniversity Hospital, Strasbourg, France

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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))

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trier Social Stress Task

    Behavioral

    Specify details not covered in associated Arm Description.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Autism Spectrum DisorderExperimental treatment 1 intervention
Group B: Attention Deficit Disorder with or without HyperactivityExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

change micro-awakening index

polysomnography

Time frame
At Day 0 and Day 3

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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