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

NCT ID: NCT02830022

Last Updated: 2018-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-11

Study Completion Date

2017-06-18

Brief Summary

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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.

Detailed Description

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Conditions

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Autonomic Nervous System Diseases Sleep

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients

Children from 8 to 18 years with autism without without intellectual disabilities (IQ \> 70), verbals and responding to classification CIM 10-DSM IV.

Group Type EXPERIMENTAL

physiological explorations

Intervention Type OTHER

Healthy volunteers

Paired for age, gender, IQ and and the practice of a physical activity strictly within the school context.

Group Type EXPERIMENTAL

physiological explorations

Intervention Type OTHER

Interventions

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physiological explorations

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Véronique BRICOUT, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Grenoble France

Michel GUINOT, Dr

Role: PRINCIPAL_INVESTIGATOR

CHU Grenoble France

Locations

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CHU Grenoble

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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38RC14.123

Identifier Type: -

Identifier Source: org_study_id

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