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

Sleep Clinical Trial

— APAUTRES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830022
• Other study ID #: 38RC14.123
• Status: Completed
• Phase: N/A
• Start date: December 11, 2013
• Est. completion date: June 18, 2017

Study information

• Verified date: October 2018
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 18, 2017
• Est. primary completion date: June 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autonomic Nervous System Diseases
• Child Development Disorders, Pervasive
• Nervous System Diseases
• Primary Dysautonomias
• Sleep

Intervention

Other:
• physiological explorations

Locations

Country	Name	City	State
France	CHU Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiorespiratory evaluation	a maximal treadmill test is proposed (evaluation of : VO² max, maximal heart rate)	1 day
Primary	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.	1 day and 3 nights
Primary	sleep evaluation	Sleep characteristics are obtained by an actimetry during 7 nights in order to observe sleep disorders.; Sleep Questionnaires are also completed.	7 nights
Secondary	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	7 days
Secondary	Motor capacities	motor capacities are evaluated by several specific tests : PANESS, M-ABS and Eurofit.	1 day
Secondary	Behavioural characteristics	Behavioural characteristics are evaluated by the Vineland scale	1 hour
Secondary	biological parameters	during the maximal treadmill test, salivary samples are made (cortisol, alpha amylase), before and after tthe test	1 day