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

NCT06479668 | Not Yet Recruiting

• 1 other identifier: 9094
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Attention Deficit Disorder With or Without Hyperactivity (ADHD); Autism Spectrum Disorder (ASD)

Outcome Measures

Primary Outcomes (1)

• change micro-awakening index

  polysomnography

  At Day 0 and Day 3

Study Arms (2)

Autism Spectrum Disorder

EXPERIMENTAL

Behavioral: Trier Social Stress Task

Attention Deficit Disorder with or without Hyperactivity

EXPERIMENTAL

Behavioral: Trier Social Stress Task

Interventions

Trier Social Stress Task BEHAVIORAL

Specify details not covered in associated Arm Description.

Attention Deficit Disorder with or without Hyperactivity; Autism Spectrum Disorder

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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))
• 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.

You may not qualify if:

• \- 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, ...)
• 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)
• 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 emergency situation

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive

Central Study Contacts

Carmen Schroder, MD

CONTACT

0033388116218; carmen.schroder@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 28, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 15, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share