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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 : Completed
First Posted : July 12, 2016
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE July 7, 2016
First Posted Date  ICMJE July 12, 2016
Last Update Posted Date October 30, 2018
Actual Study Start Date  ICMJE December 11, 2013
Actual Primary Completion Date June 11, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2016)
  • cardiorespiratory evaluation [ Time Frame: 1 day ]
    a maximal treadmill test is proposed (evaluation of : VO² max, maximal heart rate)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2016)
  • 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
  • Motor capacities [ Time Frame: 1 day ]
    motor capacities are evaluated by several specific tests : PANESS, M-ABS and Eurofit.
  • Behavioural characteristics [ Time Frame: 1 hour ]
    Behavioural characteristics are evaluated by the Vineland scale
  • biological parameters [ Time Frame: 1 day ]
    during the maximal treadmill test, salivary samples are made (cortisol, alpha amylase), before and after tthe test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep, Autonomic Nervous System and Cardiorespiratory Capacity in Autism Spectrum Disorders Children (APAUTRES)
Official Title  ICMJE Sleep, Autonomic Nervous System and Cardiorespiratory Capacity in Autism Spectrum Disorders Children
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Autonomic Nervous System Diseases
  • Sleep
Intervention  ICMJE Other: physiological explorations
Study Arms  ICMJE
  • 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.
    Intervention: Other: physiological explorations
  • Experimental: Healthy volunteers
    Paired for age, gender, IQ and and the practice of a physical activity strictly within the school context.
    Intervention: Other: physiological explorations
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2018)
78
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2016)
140
Actual Study Completion Date  ICMJE June 18, 2017
Actual Primary Completion Date June 11, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02830022
Other Study ID Numbers  ICMJE 38RC14.123
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Véronique BRICOUT, PhD CHU Grenoble France
Principal Investigator: Michel GUINOT, Dr CHU Grenoble France
PRS Account University Hospital, Grenoble
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP