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

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ClinicalTrials.gov Identifier: NCT02830022
Recruitment Status : Active, not recruiting
First Posted : July 12, 2016
Last Update Posted : July 6, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Autonomic Nervous System Diseases Sleep Other: physiological explorations

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sleep, Autonomic Nervous System and Cardiorespiratory Capacity in Autism Spectrum Disorders Children
Actual Study Start Date : December 11, 2013
Primary Completion Date : June 11, 2017
Estimated Study Completion Date : March 31, 2019

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U.S. FDA Resources

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

Primary Outcome Measures :
  1. cardiorespiratory evaluation [ Time Frame: 1 day ]
    a maximal treadmill test is proposed (evaluation of : VO² max, maximal heart rate)

  2. 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.

  3. 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.

Secondary Outcome Measures :
  1. physical activity [ Time Frame: 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

  2. Motor capacities [ Time Frame: 1 day ]
    motor capacities are evaluated by several specific tests : PANESS, M-ABS and Eurofit.

  3. Behavioural characteristics [ Time Frame: 1 hour ]
    Behavioural characteristics are evaluated by the Vineland scale

  4. biological parameters [ Time Frame: 1 day ]
    during the maximal treadmill test, salivary samples are made (cortisol, alpha amylase), before and after tthe test

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830022

CHU Grenoble
Grenoble and Rhone Alps region, France, 38
Sponsors and Collaborators
University Hospital, Grenoble
Principal Investigator: Véronique BRICOUT, PhD CHU Grenoble France
Principal Investigator: Michel GUINOT, Dr CHU Grenoble France

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02830022     History of Changes
Other Study ID Numbers: 38RC14.123
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Grenoble:
autism spectrum disorder

Additional relevant MeSH terms:
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Nervous System Diseases
Autonomic Nervous System Diseases
Primary Dysautonomias
Neurodevelopmental Disorders
Mental Disorders