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Clinical Trials/NCT02544295
NCT02544295
Unknown
Not Applicable

Based-virtual Reality Diagnosis for Neuropsychiatric Diseases and Sleep/Wake Disorders

University of Bordeaux1 site in 1 country590 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
University of Bordeaux
Enrollment
590
Locations
1
Primary Endpoint
Presence or absence of the disease
Last Updated
10 years ago

Overview

Brief Summary

The objective of this research is to develop original virtual reality scenarios and/or new virtual reality equipments to evaluate or diagnose pathologies, such as attention deficit disorders or neuropsychiatric pathologies, addiction, anxiety or depression or pathologies interfering with sleep/wake disorders.

Detailed Description

Nature of the trial: without direct individual benefit study conducted in healthy volunteers, patients with attention disorders : ADHD (Attention Deficit Disorder / Hyperactivity) and cognitive aging, addictive disorders, anxiety disorders, depressive disorders or pathologies that interfere with sleep/wake cycle. The duration of the study is 8 years. Type of trial: Comparison of two parallel groups of healthy volunteers and patients with attention disorders, addictive, anxious, depressive or interfering with sleep/wake cycle. Study design: * standardized clinical interview with a sleep specialist, psychiatrist, or psychologist and rating scales, * a virtual reality task. The primary outcome is to evaluate the diagnosis accuracy and the acceptability of the virtual tool to the referent standard (clinical interview and scales). The secondary outcomes are: * The comparison of healthy subjects and patients performances * Tolerance, acceptability to exposure to virtual scenarios.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
January 2019
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Bordeaux
Responsible Party
Principal Investigator
Principal Investigator

Pierre Philip

MD / PhD

University of Bordeaux

Eligibility Criteria

Inclusion Criteria

  • Being aged between 7 and 75 years
  • Having signed written informed consent

Exclusion Criteria

  • Having participated to a clinical trial in the previous 3 months

Outcomes

Primary Outcomes

Presence or absence of the disease

Time Frame: 1 day

Categorial diagnosis generated by the psychiatrist and by the Virtual reality task (0=absence of disease and 1 = presence of the disease)

Secondary Outcomes

  • Physiological parameters: Polysomnography (sleep structure (stage %))(1 night)
  • Sleepiness scale(1 day)
  • BDI-II questionnaire(1 day)
  • Physiological parameters: Polysomnography (Apnea/Hypopnea index and Periodic movements index (events/hr))(1 night)
  • Physiological parameters: Polysomnography (total sleep time (min))(1 night)
  • IDS-R questionnaire(1 day)
  • Acceptability scale(1 day)
  • ASRS(1 day)

Study Sites (1)

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