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

Not Applicable

Completed

• Conditions: Autonomic Nervous System Diseases; Sleep
• Interventions: Other: physiological explorations

• Registration Number: NCT02830022
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-11
• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-12
• Primary Completion: 2017-06-11
• Study Completion: 2017-06-18
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients	physiological explorations	Children from 8 to 18 years with autism without without intellectual disabilities (IQ \> 70), verbals and responding to classification CIM 10-DSM IV.
Healthy volunteers	physiological explorations	Paired for age, gender, IQ and and the practice of a physical activity strictly within the school context.

Primary Outcome Measures

Name	Time	Method
sleep evaluation	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	1 day	a maximal treadmill test is proposed (evaluation of : VO² max, maximal heart rate)
autonomic nervous system evaluation	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 Outcome Measures

Name	Time	Method
Behavioural characteristics	1 hour	Behavioural characteristics are evaluated by the Vineland scale
biological parameters	1 day	during the maximal treadmill test, salivary samples are made (cortisol, alpha amylase), before and after tthe test
physical activity	7 days	physical activity characteristics (sedentary, moderate or vigorous activities, energy expenditure) are obtained by an actimetry during 7 days.; Questionnaires of physical activity are also completed
Motor capacities	1 day	motor capacities are evaluated by several specific tests : PANESS, M-ABS and Eurofit.

Trial Locations

Locations (1)

CHU Grenoble; 🇫🇷 Grenoble, France