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

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.

Study Overview

• Status: Unknown
• Conditions: Depression; Anxiety; Aging; Addiction; Sleep Disorders; Attention Deficit Disorder With Hyperactivity; Attention Deficit
• Intervention / Treatment: Behavioral: Clinical interview; Behavioral: Virtual reality task

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.

• Study Type: Interventional
• Enrollment (Anticipated): 590
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Recruiting
    • University Hospital of Bordeaux
    • Contact: Pierre PHILIP, MD-PhD; Phone Number: +33557820172; Email: pr.philip@free.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Clinical interview; Behavioral: Virtual reality task
Experimental: 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	Behavioral: Clinical interview; Behavioral: Virtual reality task

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence of the disease	Categorial diagnosis generated by the psychiatrist and by the Virtual reality task (0=absence of disease and 1 = presence of the disease)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleepiness scale	Scores range from 0 (no sleepiness) to 24 (severe sleepiness)	1 day
BDI-II questionnaire	Beck Depression Inventory Scores range from 0 (no depression) to 63 (severe depression)	1 day
IDS-R questionnaire	Inventory of Depressive Symptomatology scores range from 0 (no depression) to 84 (severe depression)	1 day
Acceptability scale	Scores range from 0 to 36	1 day
ASRS	Adult ADHD Self-Report Scale Scores : Four or more positive answers in Part A (6 questions) are indicative of ADHD symptoms.	1 day
Physiological parameters: Polysomnography (total sleep time (min))		1 night
Physiological parameters: Polysomnography (sleep structure (stage %))		1 night
Physiological parameters: Polysomnography (Apnea/Hypopnea index and Periodic movements index (events/hr))		1 night

Collaborators and Investigators

• Sponsor: University of Bordeaux
• Investigators: Principal Investigator: Pierre PHILIP, PhD, University of Bordeaux

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: September 3, 2015
• First Submitted That Met QC Criteria: September 8, 2015
• First Posted (Estimate): September 9, 2015

Study Record Updates

• Last Update Posted (Estimate): September 9, 2015
• Last Update Submitted That Met QC Criteria: September 8, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Sleep Wake Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: UBXS 2011-02; 2011-A01418-33 (Registry Identifier: ID-RCB/EUDRACT)