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

NCT ID: NCT02544295

Last Updated: 2015-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

590 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2019-01-31

Brief Summary

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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

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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.

Conditions

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Aging Addiction Attention Deficit Disorder With Hyperactivity Sleep Disorders Anxiety Depression Attention Deficit

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Clinical interview-Virtual reality task:1

Healthy controls will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration

Group Type EXPERIMENTAL

Clinical interview

Intervention Type BEHAVIORAL

Virtual reality task

Intervention Type BEHAVIORAL

Clinical interview-Virtual reality task:2

Patients will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration

Group Type EXPERIMENTAL

Clinical interview

Intervention Type BEHAVIORAL

Virtual reality task

Intervention Type BEHAVIORAL

Interventions

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Clinical interview

Intervention Type BEHAVIORAL

Virtual reality task

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Pierre Philip

MD / PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pierre PHILIP, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bordeaux

Locations

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University Hospital of Bordeaux

Bordeaux, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre PHILIP, MD-PhD

Role: CONTACT

+33557820172

Facility Contacts

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Pierre PHILIP, MD-PhD

Role: primary

+33557820172

Other Identifiers

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2011-A01418-33

Identifier Type: REGISTRY

Identifier Source: secondary_id

UBXS 2011-02

Identifier Type: -

Identifier Source: org_study_id

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