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

Not Applicable

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

• Registration Number: NCT02544295
• Lead Sponsor: University of Bordeaux

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.

Study Timeline

• Study Start: 2012-01
• Status Verified: 2015-09
• Study First Submitted: 2015-09-03
• Study First Submitted QC: 2015-09-08
• Last Update Submitted: 2015-09-08
• Study First Posted: 2015-09-09
• Last Update Posted: 2015-09-09
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 590

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Presence or absence of the disease	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 Outcome Measures

Name	Time	Method
Physiological parameters: Polysomnography (sleep structure (stage %))	1 night
BDI-II questionnaire	1 day	Beck Depression Inventory Scores range from 0 (no depression) to 63 (severe depression)
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	Inventory of Depressive Symptomatology scores range from 0 (no depression) to 84 (severe depression)
Acceptability scale	1 day	Scores range from 0 to 36
ASRS	1 day	Adult ADHD Self-Report Scale Scores : Four or more positive answers in Part A (6 questions) are indicative of ADHD symptoms.
Sleepiness scale	1 day	Scores range from 0 (no sleepiness) to 24 (severe sleepiness)

Trial Locations

Locations (1)

University Hospital of Bordeaux; 🇫🇷 Bordeaux, France