Design Of WELL Being Monitoring Systems, Application in Autism (Do Well B)
Primary Purpose
Autistic Disorder
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
real life situations
Sponsored by
About this trial
This is an interventional prevention trial for Autistic Disorder
Eligibility Criteria
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.
Sites / Locations
- University Hospital of Clermont-Ferrand (CHU), FranceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Participants with autism
Aged-matched controls
Arm Description
Outcomes
Primary Outcome Measures
Heart Rate Variability from holter electrocardiogram
Secondary Outcome Measures
Heart Rate Variability from the heart rate transmitter belt
Full Information
NCT ID
NCT02275455
First Posted
October 14, 2014
Last Updated
July 25, 2016
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT02275455
Brief Title
Design Of WELL Being Monitoring Systems, Application in Autism
Acronym
Do Well B
Official Title
Design Of WELL Being Monitoring Systems, Application in Autism
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
The protocol will take place in real life (home and social environments). We aim to associate modifications of ANS with external events which will all be recorded in a synchrony manner through a specific design (spy glasses with video/audio recording). 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. We will apply the statistical analyses developed by our team on continuous ANS data. Detection of abrupt changes will allow segmenting the data in shorter time series of few minutes with a constant mean, and estimating their persistency or antipersistency through a piecewise constant fractal index. We will disentangle classes characterizing different behaviors such as anxiety, rest and physical activity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants with autism
Arm Type
Experimental
Arm Title
Aged-matched controls
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
real life situations
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart Rate Variability from holter electrocardiogram
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Heart Rate Variability from the heart rate transmitter belt
Time Frame
at day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Dutheil, MD PhD
Organizational Affiliation
University Hospital of Clermont-Ferrand (CHU), France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Clermont-Ferrand (CHU), France
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
25710916
Citation
Dutheil F, Chambres P, Hufnagel C, Auxiette C, Chausse P, Ghozi R, Paugam G, Boudet G, Khalfa N, Naughton G, Chamoux A, Mermillod M, Bertrand PR. 'Do Well B.': Design Of WELL Being monitoring systems. A study protocol for the application in autism. BMJ Open. 2015 Feb 20;5(2):e007716. doi: 10.1136/bmjopen-2015-007716.
Results Reference
derived
Links:
URL
http://math.univ-bpclermont.fr/DoWellB/
Description
Related Info
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Design Of WELL Being Monitoring Systems, Application in Autism
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