Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06479668
Acronym
SOM-EMO-TND
Enrollment
30
Registered
2024-06-28
Start date
2024-10-03
Completion date
2026-05-13
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

BEHAVIORALTrier Social Stress Task

Specify details not covered in associated Arm Description.

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change micro-awakening indexAt Day 0 and Day 3polysomnography

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026