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

University of Bordeaux

Status: Unknown

Conditions: Sleep Disorders; Aging; Attention Deficit Disorder With Hyperactivity; Addiction; Attention Deficit; Depression; Anxiety

Treatments: Behavioral: Virtual reality task; Behavioral: Clinical interview

Study type: Interventional

Funder types: Other

Identifiers

NCT02544295

UBXS 2011-02

2011-A01418-33 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 590 estimated patients

Sex: All

Ages: 7 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

590 participants in 2 patient groups

Clinical interview-Virtual reality task:1

Experimental group

Description:

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

Treatment:

Behavioral: Clinical interview

Behavioral: Virtual reality task

Clinical interview-Virtual reality task:2

Experimental group

Description:

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

Treatment:

Behavioral: Clinical interview

Behavioral: Virtual reality task