title: 'Do Well B.': Design Of WELL Being monitoring systems. A study protocol for the application in autism.
abstract: BACKGROUND
  Individuals with autism spectrum disorder (ASD) have difficulties in communication and social interaction resulting from atypical perceptual and cognitive information processing, leading to an accumulation of anxiety. Extreme overloading experienced internally may not be externally visible. Identifying stressful situations at an early stage may avoid socially problematic behaviour from occurring, such as self-injurious behaviour. 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 portable devices, non-intrusively and pain-free. Thus, developing innovative analysis of signal perception and reaction is necessary, mainly for non-communicative individuals with autism.
  
  
  METHODS
  The protocol will take place in real life (home and social environments). We aim to associate modifications of the ANS with external events that will be recorded in a synchronous manner through a specific design (spy glasses with video/audio recording). Four phases will be carried out on ASD participants and aged-matched controls: (1) 24-hour baseline pre-experiment (physical activity, sleep), (2) 2 h in a real life situation, (3) 30 min in a quiet environment, interrupted by a few seconds of stressful sound, (4) an interview to record feelings about events triggering anxiety. ASD 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. The novelty will be to apply time-series analyses (which led to several Nobel Prizes in quantitative finance) on ANS series (heart rate, heart rate variability, skin conductance) and wrist motion.
  
  
  BACKGROUND
  Ethical approval has been obtained from Ethics Committee of Clermont-Ferrand (South-East I), France (2014-A00611-46). Trial findings will be disseminated via open-access peer-reviewed publications, conferences, clinical networks, public lectures and our websites.
  
  
  BACKGROUND
  ClinicalTrials identifier NCT02275455.
authors.affiliation: Department of Preventive and Occupational Medicine, University Hospital of Clermont-Ferrand (CHU), Clermont-Ferrand, France School of Exercise Science, Australian Catholic University, Melbourne, Victoria, Australia Laboratory of Metabolic Adaptations to Exercise in Physiological and Pathological Conditions, Clermont University, Blaise Pascal University, Aubière, France Human Nutrition Unit (UNH), Research Centre in Human Nutrition (CRNH), INRA, Clermont-Ferrand, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Dutheil
authors.affiliation: Clermont Université, Université Blaise Pascal, Laboratoire de Psychologie Sociale et Cognitive, Clermont-Ferrand, France CNRS, UMR 6024, LaPSCo, Clermont-Ferrand, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Chambres
authors.affiliation: Clermont Université, Université Blaise Pascal, Laboratoire de Psychologie Sociale et Cognitive, Clermont-Ferrand, France CNRS, UMR 6024, LaPSCo, Clermont-Ferrand, France.
authors.forename: Cédric
authors.initials: C
authors.lastname: Hufnagel
authors.affiliation: Clermont Université, Université Blaise Pascal, Laboratoire de Psychologie Sociale et Cognitive, Clermont-Ferrand, France CNRS, UMR 6024, LaPSCo, Clermont-Ferrand, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Auxiette
authors.affiliation: Laboratory of Metabolic Adaptations to Exercise in Physiological and Pathological Conditions, Clermont University, Blaise Pascal University, Aubière, France Clermont Université, Université Blaise Pascal, Laboratoire de Psychologie Sociale et Cognitive, Clermont-Ferrand, France CNRS, UMR 6024, LaPSCo, Clermont-Ferrand, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Chausse
authors.affiliation: Signals and Systems Research Unit, National Engineering School of Tunis, El Manar University, Tunis, Tunisia.
authors.forename: Raja
authors.initials: R
authors.lastname: Ghozi
authors.affiliation: Clermont Université, Université Blaise Pascal, Laboratoire de Mathématiques, Clermont-Ferrand, France CNRS, UMR 6620, LM, Clermont-Ferrand, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Paugam
authors.affiliation: Department of Preventive and Occupational Medicine, University Hospital of Clermont-Ferrand (CHU), Clermont-Ferrand, France.
authors.forename: Gil
authors.initials: G
authors.lastname: Boudet
authors.affiliation: Signals and Systems Research Unit, National Engineering School of Tunis, El Manar University, Tunis, Tunisia.
authors.forename: Nadia
authors.initials: N
authors.lastname: Khalfa
authors.affiliation: School of Exercise Science, Australian Catholic University, Melbourne, Victoria, Australia.
authors.forename: Geraldine
authors.initials: G
authors.lastname: Naughton
authors.affiliation: Department of Preventive and Occupational Medicine, University Hospital of Clermont-Ferrand (CHU), Clermont-Ferrand, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Chamoux
authors.affiliation: Univ Grenoble Alpes, LPNC, Grenoble, France CNRS, UMR 5105, LPNC, Grenoble, France Institut Universitaire de France, Paris, France.
authors.forename: Martial
authors.initials: M
authors.lastname: Mermillod
authors.affiliation: Clermont Université, Université Blaise Pascal, Laboratoire de Mathématiques, Clermont-Ferrand, France CNRS, UMR 6620, LM, Clermont-Ferrand, France.
authors.forename: Pierre Raphael
authors.initials: PR
authors.lastname: Bertrand
mesh_terms: D000223:Adaptation, Psychological; D001007:Anxiety / Q000503:physiopathology / Q000523:psychology* / Q000628:therapy; D001321:Autistic Disorder / Q000503:physiopathology / Q000523:psychology* / Q000628:therapy; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003142:Communication; D006801:Humans; D007398:Interpersonal Relations; D010549:Personal Satisfaction; D016728:Self-Injurious Behavior / Q000517:prevention & control*; D012919:Social Behavior; D012931:Social Environment; D013315:Stress, Psychological; D016896:Treatment Outcome
keywords: CLINICAL PHYSIOLOGY; PREVENTIVE MEDICINE; PUBLIC HEALTH; STATISTICS & RESEARCH METHODS