Autism Spectrum Disorder With Intellectual DeficiencySTRESSDEFISNCT07535801
Recording Stress Biomarkers in Autism Spectrum Disorders
An observational study of Autism Spectrum Disorder With Intellectual Deficiency, run by Universite Cote d'Azur at 1 site in France.
Trial summary
The goal of this observational study is to learn how stress affects children and young people with autism spectrum disorder (ASD). Many individuals with autism experience strong stress reactions that may lead to challenging behaviours such as agitation, withdrawal, aggression, or self-injury. Read more about this study
- Who is it for?
- Ages 3 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder With Intellectual Deficiency
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2026to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population consists of children and adolescents aged 3 to 22 years. Two groups are included: individuals diagnosed with autism spectrum disorder (ASD) presenting recurrent behavioral crises, and a neurotypical control group without neurodevelopmental disorders. Participants with ASD are recruited from specialized medico-social institutions providing care and educational support for individuals with neurodevelopmental conditions. Control participants are recruited from the general population through community outreach and school-based information to families. Participants are observed during their regular daily activities in naturalistic environments such as specialized institutions, schools, or home settings. Continuous physiological monitoring, behavioral observation, and biological sampling are conducted during daytime institutional sessions.
Who may be able to join
None listed.
Who cannot join
- Known cardiac or homonal disorders that may interfere with physiological monitoring
- Lack of consent from parents or legal guardians
- Control Group (Neurotypical Participants) Inclusion Criteria
- Age between 3 and 22 years
- No diagnosis of autism spectrum disorder or other neurodevelopmental disorder
- No history of major psychiatric or neurological disorders
Show all 11Show fewer
- Written informed consent provided by a parent or legal guardian
- Assent from the participant when developmentally appropriate
- Known cardiac or hormonal disorders affecting physiological measurements
- Current diagnosis of neurodevelopmental or psychiatric disorder
- Lack of parental or guardian consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CoBTEk
Nice, 06100
Susanne THÜMMLER, MDC- HDR -PhD, +33 4 92 03 03 26, Susanne.THUMMLER@univ-cotedazur.fr
About this study
Official title: Biophysiological Characterization of Stress in Autism Spectrum Disorders: Analysis of Peripheral Markers of the ANS and the HPA Axis
The goal of this observational study is to learn how stress affects children and young people with autism spectrum disorder (ASD). Many individuals with autism experience strong stress reactions that may lead to challenging behaviours such as agitation, withdrawal, aggression, or self-injury. These behaviours can be difficult to predict, especially in people who have limited communication abilities.
Researchers want to better understand how the body reacts to stress in real-life situations. The study focuses on two main biological systems involved in the stress response:
Read more
the autonomic nervous system, which produces fast reactions such as changes in heart rate and sweating, and the hypothalamic-pituitary-adrenal axis, which produces slower hormonal responses such as cortisol.
The main questions the study aims to answer are:
- Do physiological stress signals differ between individuals with ASD and those without ASD?
- Are there differences in physiological stress responses between individuals with ASD and non-ASD participants?
- Can physiological markers help identify stress earlier in people with autism?
Researchers will compare children and young people with autism to a control group of participants without autism to see whether their stress responses differ.
Participants will take part in monitoring during their normal daily activities. This allows researchers to observe stress responses in natural environments such as school, home, or specialized care institutions.
Participants will:
- Wear a wrist device during the day that measures heart rate, heart rate variability, skin conductance, skin temperature, and movement
- Provide saliva samples in the morning and afternoon to measure stress hormones such as cortisol and alpha-amylase
- Have additional saliva samples collected after behavioural crises or stressful events when possible
- Be observed by a trained researcher who records behavioural events and the surrounding context
Researchers will combine physiological data, behavioural observations, and contextual information such as physical activity, environmental conditions, and daily routines. This will help identify patterns of stress in everyday life.
The results of this study may help researchers better understand the physiology of stress in autism and support the future development of wearable systems that could detect stress early and help prevent behavioural crises.
- Keywords
- autism spectrum disorder, stress biomarkers, autonomic nervous system, heart rate variability, challenging behavior, ecological assessment, profound autism, hypothalamic-pituitary-adrenal axis, skin conductance, salivary cortisol, salivary alpha amylase
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder Participants | The cohort includes children and adolescents aged 3 to 22 years with a clinical diagnosis of autism spectrum disorder (ASD). Participants are recruited from specialized medico-social institutions providing care and educational support for individuals with neurodevelopmental disorders. To be eligible for inclusion, participants must present frequent challenging behaviours, defined as at least three behavioural crises per week (e.g., agitation, aggression, self-injurious behaviours, or severe emotional dysregulation). Participants must also be able to tolerate the placement of a wearable physiological monitoring device during daytime activities. Participants with known cardiac disorders or hormonal disorders that may affect physiological stress measurements are excluded. Written informed consent is obtained from parent | |
| Neurotypical Participants | The control cohort includes children and adolescents aged 3 to 22 years from the general population. Participants in this group do not have a diagnosis of autism spectrum disorder or other neurodevelopmental disorders. Control participants are recruited through community outreach, schools and information provided to families. They are selected to be comparable to the ASD group in terms of age and sex as closely as possible. Participants with known cardiac disorders or hormonal disorders that may affect physiological stress measurements are excluded. Written informed consent is obtained from parents or legal guardians prior to participation. The control participants follow the same monitoring procedures as the ASD group during their usual daily activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic Physiological Stress Markers During Behavioral Stress Episodes
Continuous autonomic physiological signals are recorded using a wearable device during daytime monitoring. The primary outcome consists of variations in autonomic stress markers including heart rate (HR), heart rate variability (HRV), and electrodermal activity (EDA) in relation to behavioral stress events and crisis episodes recorded during observation. These physiological signals will be analyzed to identify changes associated with stress states and behavioral dysregulation in naturalistic settings.
Measured: Continuous monitoring during the 4-day observation period (approximately 8 hours per day).
Secondary outcomes (3)
Salivary Cortisol Concentration
Salivary cortisol levels are measured as a biomarker of hypothalamic-pituitary-adrenal (HPA) axis activation. Samples are collected twice daily (morning and afternoon) and after behavioral crisis events when feasible. Cortisol concentrations are quantified using enzyme-linked immunosorbent assay (ELISA) techniques.
Measured: Collected during the 4-day observation period (morning, afternoon, and post-crisis when applicable).
Salivary Alpha-Amylase Activity
Salivary alpha-amylase activity is measured as an indicator of sympathetic nervous system activation. Samples are collected using passive saliva swabs and analyzed using a kinetic enzymatic assay.
Measured: Collected during the 4-day observation period (morning, afternoon, and post-crisis when applicable).
Frequency and Duration of Behavioral Stress Episodes
Behavioral stress indicators and crisis episodes are recorded using a structured Antecedent-Behavior-Consequence (ABC) observation grid completed by the investigator during the monitoring period. Outcomes include the frequency and duration of behavioral dysregulation events such as agitation, self-injurious behavior, aggressive behavior, withdrawal, and emotional distress
Measured: Recorded continuously during the 4-day observation period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start23 Mar 2026
- Primary completionSep 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder With Intellectual DeficiencyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universite Cote d'Azur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Thümmler, Universite Cote d'Azur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535801
- Sponsor's protocol ID
- 25.03788.000456
- Acronym
- STRESSDEFIS
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biophysiological Characterization of Stress in Autism Spectrum Disorders: Analysis of Peripheral Markers of the ANS and the HPA Axis
- ClinicalTrials.gov ID
- NCT07535801
- Acronym / sponsor ID
- STRESSDEFIS / 25.03788.000456
- Keywords
- autism spectrum disorder, stress biomarkers, autonomic nervous system, heart rate variability, challenging behavior, ecological assessment, profound autism, hypothalamic-pituitary-adrenal axis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universite Cote d'AzurUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 17 Apr 2026 (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 goal of this observational study is to learn how stress affects children and young people with autism spectrum disorder (ASD). Many individuals with autism experience strong stress reactions that may lead to challenging behaviours such as agitation, withdrawal, aggression, or self-injury. These behaviours can be difficult to predict, especially in people who have limited communication abilities.
Researchers want to better understand how the body reacts to stress in real-life situations. The study focuses on two main biological systems involved in the stress response:
the autonomic nervous system, which produces fast reactions such as changes in heart rate and sweating, and the hypothalamic-pituitary-adrenal axis, which produces slower hormonal responses such as cortisol.
The main questions the study aims to answer are:
- Do physiological stress signals differ between individuals with ASD and those without ASD?
- Are there differences in physiological stress responses between individuals with ASD and non-ASD participants?
- Can physiological markers help identify stress earlier in people with autism?
Researchers will compare children and young people with autism to a control group of participants without autism to see whether their stress responses differ.
Participants will take part in monitoring during their normal daily activities. This allows researchers to observe stress responses in natural environments such as school, home, or specialized care institutions.
Participants will:
- Wear a wrist device during the day that measures heart rate, heart rate variability, skin conductance, skin temperature, and movement
- Provide saliva samples in the morning and afternoon to measure stress hormones such as cortisol and alpha-amylase
- Have additional saliva samples collected after behavioural crises or stressful events when possible
- Be observed by a trained researcher who records behavioural events and the surrounding context
Researchers will combine physiological data, behavioural observations, and contextual information such as physical activity, environmental conditions, and daily routines. This will help identify patterns of stress in everyday life.
The results of this study may help researchers better understand the physiology of stress in autism and support the future development of wearable systems that could detect stress early and help prevent behavioural crises.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder Participants | – | –The cohort includes children and adolescents aged 3 to 22 years with a clinical diagnosis of autism spectrum disorder (ASD). Participants are recruited from specialized medico-social institutions providing care and educational support for individuals with neurodevelopmental disorders. To be eligible for inclusion, participants must present frequent challenging behaviours, defined as at least three behavioural crises per week (e.g., agitation, aggression, self-injurious behaviours, or severe emotional dysregulation). Participants must also be able to tolerate the placement of a wearable physiological monitoring device during daytime activities. Participants with known cardiac disorders or hormonal disorders that may affect physiological stress measurements are excluded. Written informed consent is obtained from parent |
| Neurotypical Participants | – | –The control cohort includes children and adolescents aged 3 to 22 years from the general population. Participants in this group do not have a diagnosis of autism spectrum disorder or other neurodevelopmental disorders. Control participants are recruited through community outreach, schools and information provided to families. They are selected to be comparable to the ASD group in terms of age and sex as closely as possible. Participants with known cardiac disorders or hormonal disorders that may affect physiological stress measurements are excluded. Written informed consent is obtained from parents or legal guardians prior to participation. The control participants follow the same monitoring procedures as the ASD group during their usual daily activities. |
Who may qualify
- Ages
- 3 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of children and adolescents aged 3 to 22 years. Two groups are included: individuals diagnosed with autism spectrum disorder (ASD) presenting recurrent behavioral crises, and a neurotypical control group without neurodevelopmental disorders. Participants with ASD are recruited from specialized medico-social institutions providing care and educational support for individuals with neurodevelopmental conditions. Control participants are recruited from the general population through community outreach and school-based information to families. Participants are observed during their regular daily activities in naturalistic environments such as specialized institutions, schools, or home settings. Continuous physiological monitoring, behavioral observation, and biological sampling are conducted during daytime institutional sessions.
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Control Group (Neurotypical Participants) Inclusion Criteria
- Known cardiac or hormonal disorders affecting physiological measurements
- Current diagnosis of neurodevelopmental or psychiatric disorder
- Lack of parental or guardian consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Autonomic Physiological Stress Markers During Behavioral Stress Episodes
Time frame: Continuous monitoring during the 4-day observation period (approximately 8 hours per day).
Continuous autonomic physiological signals are recorded using a wearable device during daytime monitoring. The primary outcome consists of variations in autonomic stress markers including heart rate (HR), heart rate variability (HRV), and electrodermal activity (EDA) in relation to behavioral stress events and crisis episodes recorded during observation. These physiological signals will be analyzed to identify changes associated with stress states and behavioral dysregulation in naturalistic settings.
3 secondary outcomes
Salivary Cortisol Concentration
Time frame: Collected during the 4-day observation period (morning, afternoon, and post-crisis when applicable).
Salivary Alpha-Amylase Activity
Time frame: Collected during the 4-day observation period (morning, afternoon, and post-crisis when applicable).
Frequency and Duration of Behavioral Stress Episodes
Time frame: Recorded continuously during the 4-day observation period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Yes
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Neurodevelopmental Disorders, Autism Spectrum Disorder
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder With Intellectual Deficiency, run by Universite Cote d'Azur 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 0 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 23 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanne THÜMMLER, MDC- HDR -PhD (+33 4 92 03 03 26, Susanne.THUMMLER@univ-cotedazur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic Physiological Stress Markers During Behavioral Stress Episodes (time frame: Continuous monitoring during the 4-day observation period (approximately 8 hours per day).). 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 23 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.