Design Of WELL Being Monitoring Systems, Application in Autism (Do Well B)
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ClinicalTrials.gov Identifier: NCT02275455 |
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Clermont-Ferrand.
Recruitment status was: Recruiting
First Posted : October 27, 2014
Last Update Posted : July 26, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autistic Disorder | Behavioral: real life situations | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Design Of WELL Being Monitoring Systems, Application in Autism |
Study Start Date : | October 2014 |
Estimated Primary Completion Date : | December 2016 |
Estimated Study Completion Date : | December 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: Participants with autism |
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. |
Experimental: Aged-matched controls |
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. |
- Heart Rate Variability from holter electrocardiogram [ Time Frame: at day 1 ]
- Heart Rate Variability from the heart rate transmitter belt [ Time Frame: at day 1 ]

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Ages Eligible for Study: | 12 Years to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Clear autism spectrum disorder, based on the autism diagnostic interview - revised (ADI-R), the autism diagnostic observation schedule - generic (ADOS-G), and the Vineland adaptive behavior scales (VABS).
Exclusion Criteria:
- change in medical prescription in the previous 3 months and during the experiment.
The same inclusion criteria will apply for the paired age and sex matched individuals with the exception of autism spectrum. The paired control will be chosen within the friends of individuals with autism. In case of difficulty to recruit controls, the psychologist referent may be served as control.

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): NCT02275455
Contact: Patrick LACARIN | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
France | |
University Hospital of Clermont-Ferrand (CHU), France | Recruiting |
Clermont-Ferrand, France, 63000 | |
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr |
Principal Investigator: | Frédéric Dutheil, MD PhD | University Hospital of Clermont-Ferrand (CHU), France |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University Hospital, Clermont-Ferrand |
ClinicalTrials.gov Identifier: | NCT02275455 |
Other Study ID Numbers: |
CHU-0213 2014-A00611-46 ( Registry Identifier: 2014-A00611-46 ) |
First Posted: | October 27, 2014 Key Record Dates |
Last Update Posted: | July 26, 2016 |
Last Verified: | July 2016 |
Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |