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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder (ASD); Attention Deficit Disorder With or Without Hyperactivity (ADHD)
• Intervention / Treatment: Behavioral: Trier Social Stress Task

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carmen Schroder, MD; Phone Number: 0033388116218; Email: carmen.schroder@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autism Spectrum Disorder	Behavioral: Trier Social Stress Task; Specify details not covered in associated Arm Description.
Experimental: Attention Deficit Disorder with or without Hyperactivity	Behavioral: Trier Social Stress Task; Specify details not covered in associated Arm Description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change micro-awakening index	polysomnography	At Day 0 and Day 3

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): June 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Child Development Disorders, Pervasive; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Neurodevelopmental Disorders
• Other Study ID Numbers: 9094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No