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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Autonomic Nervous System Diseases
• Intervention / Treatment: Other: physiological explorations

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38100
    • CHU Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiorespiratory evaluation	a maximal treadmill test is proposed (evaluation of : VO² max, maximal heart rate)	1 day
autonomic nervous system evaluation	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.	1 day and 3 nights
sleep evaluation	Sleep characteristics are obtained by an actimetry during 7 nights in order to observe sleep disorders. Sleep Questionnaires are also completed.	7 nights

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physical activity	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	7 days
Motor capacities	motor capacities are evaluated by several specific tests : PANESS, M-ABS and Eurofit.	1 day
Behavioural characteristics	Behavioural characteristics are evaluated by the Vineland scale	1 hour
biological parameters	during the maximal treadmill test, salivary samples are made (cortisol, alpha amylase), before and after tthe test	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Véronique BRICOUT, PhD, CHU Grenoble France; Principal Investigator: Michel GUINOT, Dr, CHU Grenoble France

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 11, 2013
• Primary Completion (ACTUAL): June 11, 2017
• Study Completion (ACTUAL): June 18, 2017

Study Registration Dates

• First Submitted: July 7, 2016
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (ESTIMATE): July 12, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: autism spectrum disorder
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Nervous System Diseases; Autism Spectrum Disorder; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: 38RC14.123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO