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

Primary Purpose

Autonomic Nervous System Diseases, Sleep

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
physiological explorations
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Autonomic Nervous System Diseases focused on measuring autism spectrum disorder

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients

Healthy volunteers

Arm Description

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

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

Outcomes

Primary Outcome Measures

cardiorespiratory evaluation
a maximal treadmill test is proposed (evaluation of : VO² max, maximal heart rate)
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.
sleep evaluation
Sleep characteristics are obtained by an actimetry during 7 nights in order to observe sleep disorders. Sleep Questionnaires are also completed.

Secondary Outcome Measures

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
Motor capacities
motor capacities are evaluated by several specific tests : PANESS, M-ABS and Eurofit.
Behavioural characteristics
Behavioural characteristics are evaluated by the Vineland scale
biological parameters
during the maximal treadmill test, salivary samples are made (cortisol, alpha amylase), before and after tthe test

Full Information

First Posted
July 7, 2016
Last Updated
October 26, 2018
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT02830022
Brief Title
Sleep, Autonomic Nervous System and Cardiorespiratory Capacity in Autism Spectrum Disorders Children (APAUTRES)
Acronym
APAUTRES
Official Title
Sleep, Autonomic Nervous System and Cardiorespiratory Capacity in Autism Spectrum Disorders Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 11, 2013 (Actual)
Primary Completion Date
June 11, 2017 (Actual)
Study Completion Date
June 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autonomic Nervous System Diseases, Sleep
Keywords
autism spectrum disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
Children from 8 to 18 years with autism without without intellectual disabilities (IQ > 70), verbals and responding to classification CIM 10-DSM IV.
Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Description
Paired for age, gender, IQ and and the practice of a physical activity strictly within the school context.
Intervention Type
Other
Intervention Name(s)
physiological explorations
Primary Outcome Measure Information:
Title
cardiorespiratory evaluation
Description
a maximal treadmill test is proposed (evaluation of : VO² max, maximal heart rate)
Time Frame
1 day
Title
autonomic nervous system evaluation
Description
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.
Time Frame
1 day and 3 nights
Title
sleep evaluation
Description
Sleep characteristics are obtained by an actimetry during 7 nights in order to observe sleep disorders. Sleep Questionnaires are also completed.
Time Frame
7 nights
Secondary Outcome Measure Information:
Title
physical activity
Description
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
Time Frame
7 days
Title
Motor capacities
Description
motor capacities are evaluated by several specific tests : PANESS, M-ABS and Eurofit.
Time Frame
1 day
Title
Behavioural characteristics
Description
Behavioural characteristics are evaluated by the Vineland scale
Time Frame
1 hour
Title
biological parameters
Description
during the maximal treadmill test, salivary samples are made (cortisol, alpha amylase), before and after tthe test
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Véronique BRICOUT, PhD
Organizational Affiliation
CHU Grenoble France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michel GUINOT, Dr
Organizational Affiliation
CHU Grenoble France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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