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临床试验/NCT02830022
NCT02830022已完成不适用

Sleep, Autonomic Nervous System and Cardiorespiratory Capacity in Autism Spectrum Disorders Children

University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2013年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
2
主要终点
sleep evaluation

研究概览

简要总结

Autism Spectrum Disorders (ASD) is a neurodevelopmental disorder which involves social and behavioural impairments. Autonomic dysfunctions and disturbed sleep were often associated to ASD. The investigators proposed to explore the impact of physical activity on these disorders. In this context, it is necessary to characterize the cardiorespiratory capacities of ASD children in order to promote physical activity for this population. To examine potential differences between ASD and control children, some explorations were proposed: a maximal treadmill test, motor evaluation, and orthostatic test (for the evaluation of autonomic nervous system).

An actimetry during one week (evaluation of physical activity and sleep) completed this study in order to specify sleep characteristic and established the possible link between physical activity sleep characteristics and physical fitness in ASD children.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children physically active
  • children with an intellectual quotient >70
  • for autism children a diagnosis of autism in accordance to DSMV

排除标准

  • history of cardio-vascular disease
  • history of asthma or respiratory disease
  • Behavior disorders.
  • medical treatment by neuroleptic or melatonin or antiepileptic

结局指标

主要结局

sleep evaluation

时间窗: 7 nights

Sleep characteristics are obtained by an actimetry during 7 nights in order to observe sleep disorders. Sleep Questionnaires are also completed.

cardiorespiratory evaluation

时间窗: 1 day

a maximal treadmill test is proposed (evaluation of : VO² max, maximal heart rate)

autonomic nervous system evaluation

时间窗: 1 day and 3 nights

an orthostatic test is proposed in order to verify the ANS adaptation. A nocturnal recording is made during three nights in order to verify the possible link between the rest autonomic adaptations and a possible dysautonomia observed with the orthostatic test.

次要结局

  • Behavioural characteristics(1 hour)
  • biological parameters(1 day)
  • physical activity(7 days)
  • Motor capacities(1 day)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (2)

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