Sleep, Autonomic Nervous System and Cardiorespiratory Capacity in Autism Spectrum Disorders Children (APAUTRES) (APAUTRES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02830022|
Recruitment Status : Active, not recruiting
First Posted : July 12, 2016
Last Update Posted : July 6, 2017
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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|
- 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.
- 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
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
|Grenoble and Rhone Alps region, France, 38|
|Principal Investigator:||Véronique BRICOUT, PhD||CHU Grenoble France|
|Principal Investigator:||Michel GUINOT, Dr||CHU Grenoble France|