Biophysiological Characterization of Stress in Autism Spectrum Disorders: Analysis of Peripheral Markers of the ANS and the HPA Axis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Autonomic Physiological Stress Markers During Behavioral Stress Episodes
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Autonomic Physiological Stress Markers During Behavioral Stress Episodes
时间窗: 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.
次要结局
- Salivary Cortisol Concentration(Collected during the 4-day observation period (morning, afternoon, and post-crisis when applicable).)
- Salivary Alpha-Amylase Activity(Collected during the 4-day observation period (morning, afternoon, and post-crisis when applicable).)
- Frequency and Duration of Behavioral Stress Episodes(Recorded continuously during the 4-day observation period.)
研究者
Susanne Thümmler
Principal investigor
Universite Cote d'Azur