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Clinical Trials/NCT02830022
NCT02830022
Completed
N/A

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

University Hospital, Grenoble1 site in 1 country78 target enrollmentDecember 11, 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autonomic Nervous System Diseases
Sponsor
University Hospital, Grenoble
Enrollment
78
Locations
1
Primary Endpoint
sleep evaluation
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 11, 2013
End Date
June 18, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

sleep evaluation

Time Frame: 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

Time Frame: 1 day

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

autonomic nervous system evaluation

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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