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Design Of WELL Being Monitoring Systems, Application in Autism

NCT02275455 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-07-26

No results posted yet for this study

Summary

The worldwide prevalence of autism is constantly increasing. People with autisms have difficulties in communication and social interaction resulting from atypical perceptual and information processing, leading to the accumulation of anxiety. Extreme overloading experienced internally may not be visible externally. Identifying stressful situations at an early stage may avoid socially problematic behavior from occurring, such as self-injurious behavior. Activation of the autonomous nervous system (ANS) is involved in the response to anxiety, which can be measured through heart rate variability and skin conductance with the use of a portable device, non-intrusively and pain-free. Thus, developing innovative analysis of signal perception and reaction is necessary, mainly for the non-communicative individuals with autism.

Conditions

  • Autistic Disorder

Interventions

BEHAVIORAL

real life situations

Four phases will be carried out on autism participants and aged-marched controls: 1) 24-hour baseline pre-experiment (physical activity, sleep), 2) 2-hour in real life situation, 3) 30-minute in a quiet environment, interrupted by a few seconds stressful sound, 4) an interview to get comments and feelings about events that triggered anxiety. Autism and control participants will be together for phases 2 and 3, revealing different physiological responses to the same situations, and thus identifying potentially problematic events.

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Frédéric Dutheil, MD PhD · University Hospital of Clermont-Ferrand (CHU), France

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-12-31
Completion
2018-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02275455 on ClinicalTrials.gov