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Completed

NCT Number: NCT02830022

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

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.

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Key information

Conditions

Autonomic Nervous System Diseases Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Sleep

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Grenoble

Grenoble, 38100, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physiological explorations

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: APAUTRES

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 12, 2016
Registry last updated
Oct 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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