Attention Deficit Disorder With or Without Hyperactivity (ADHD)SOM-EMO-TNDNCT06479668
Characterize the Links Between Sleep, Emotional Dysregulation and Learning in Neurodevelopmental Disorders.
A study testing Trier Social Stress Task in people with Attention Deficit Disorder With or Without Hyperactivity (ADHD) and Autism Spectrum Disorder (ASD), run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With or Without Hyperactivity (ADHD), Autism Spectrum Disorder (ASD)
- What is being tested?
- Trier Social Stress Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2024to 13 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpitaux Universitaires de Strasbourg
Strasbourg, Grand Est, 67000
About this study
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)
- Being tested
- Trier Social Stress Task
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trier Social Stress TaskBehavioural
Specify details not covered in associated Arm Description.
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder | Experimental | Not described Receives: Behavioral: Trier Social Stress Task |
| Attention Deficit Disorder with or without Hyperactivity | Experimental | Not described Receives: Behavioral: Trier Social Stress Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
change micro-awakening index
polysomnography
Measured: At Day 0 and Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start3 Oct 2024
- Primary completion13 May 2026
- Study completion13 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With or Without Hyperactivity (ADHD)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479668
- Sponsor's protocol ID
- 9094
- Acronym
- SOM-EMO-TND
- Status last verified
- Aug 2026
- First submitted
- 21 Jun 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterize the Links Between Sleep, Emotional Dysregulation and Learning in Neurodevelopmental Disorders.
- ClinicalTrials.gov ID
- NCT06479668
- Acronym / sponsor ID
- SOM-EMO-TND / 9094
- Conditions
- Attention Deficit Disorder With or Without Hyperactivity (ADHD), Autism Spectrum Disorder (ASD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 13 May 2026 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder | Experimental | Behavioral: Trier Social Stress Task |
| Attention Deficit Disorder with or without Hyperactivity | Experimental | Behavioral: Trier Social Stress Task |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trier Social Stress TaskSpecify details not covered in associated Arm Description. | Behavioural | Attention Deficit Disorder with or without Hyperactivity, Autism Spectrum Disorder |
Primary outcome
change micro-awakening index
Time frame: At Day 0 and Day 3
polysomnography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trier Social Stress Task in people with Attention Deficit Disorder With or Without Hyperactivity (ADHD) and Autism Spectrum Disorder (ASD), run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change micro-awakening index (time frame: At Day 0 and Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.