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Recording Stress Biomarkers in Autism Spectrum Disorders

Recruitingn/aAges 3 Years - 22 YearsAllUniversite Cote d'Azur
NCT07535801 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
1. Autism Spectrum Disorder (ASD) Group Inclusion Criteria * Age between 3 and 22 years * Clinical diagnosis of autism spectrum disorder according to established diagnostic criteria * Presence of recurrent behavioral crises (minimum of three episodes per week) * Enrollment in a participating institution or care structure * Written informed consent provided by a parent or legal guardian * Assent from the participant when developmentally appropriate Exclusion Criteria: * Known cardiac or homonal disorders that may interfere with physiological monitoring * Lack of consent from parents or legal guardians 2. 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 * Written informed consent provided by a parent or legal guardian * Assent from the participant when developmentally appropriate Exclusion Criteria * Known cardiac or hormonal disorders affecting physiological measurements * Current diagnosis of neurodevelopmental or psychiatric disorder * Lack of parental or guardian consent
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What it tests

  • Not listed
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Where

1 site
CoBTEk
Nice, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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