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临床试验/NCT02275455
NCT02275455Unknown不适用

Design Of WELL Being Monitoring Systems, Application in Autism

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Heart Rate Variability from holter electrocardiogram

研究概览

简要总结

The worldwide prevalence of autism is constantly increasing. People with autisms have difficulties in communication and social interaction resulting from atypical perceptual and information processing, leading to the accumulation of anxiety. Extreme overloading experienced internally may not be visible externally. Identifying stressful situations at an early stage may avoid socially problematic behavior from occurring, such as self-injurious behavior. Activation of the autonomous nervous system (ANS) is involved in the response to anxiety, which can be measured through heart rate variability and skin conductance with the use of a portable device, non-intrusively and pain-free. Thus, developing innovative analysis of signal perception and reaction is necessary, mainly for the non-communicative individuals with autism.

详细描述

The protocol will take place in real life (home and social environments). We aim to associate modifications of ANS with external events which will all be recorded in a synchrony manner through a specific design (spy glasses with video/audio recording). Four phases will be carried out on autism participants and aged-marched controls: 1) 24-hour baseline pre-experiment (physical activity, sleep), 2) 2-hour in real life situation, 3) 30-minute in a quiet environment, interrupted by a few seconds stressful sound, 4) an interview to get comments and feelings about events that triggered anxiety. Autism and control participants will be together for phases 2 and 3, revealing different physiological responses to the same situations, and thus identifying potentially problematic events. We will apply the statistical analyses developed by our team on continuous ANS data. Detection of abrupt changes will allow segmenting the data in shorter time series of few minutes with a constant mean, and estimating their persistency or antipersistency through a piecewise constant fractal index. We will disentangle classes characterizing different behaviors such as anxiety, rest and physical activity.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Clear autism spectrum disorder, based on the autism diagnostic interview - revised (ADI-R), the autism diagnostic observation schedule - generic (ADOS-G), and the Vineland adaptive behavior scales (VABS).

排除标准

  • change in medical prescription in the previous 3 months and during the experiment.
  • The same inclusion criteria will apply for the paired age and sex matched individuals with the exception of autism spectrum. The paired control will be chosen within the friends of individuals with autism. In case of difficulty to recruit controls, the psychologist referent may be served as control.

结局指标

主要结局

Heart Rate Variability from holter electrocardiogram

时间窗: at day 1

次要结局

  • Heart Rate Variability from the heart rate transmitter belt(at day 1)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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