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

Depression Clinical Trial

— PHENOVIRTPSY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02544295
• Other study ID #: UBXS 2011-02
• Secondary ID: 2011-A01418-33
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2015
• Last updated: September 8, 2015
• Start date: January 2012
• Est. completion date: January 2019

Study information

• Verified date: September 2015
• Source: University of Bordeaux
• Contact: Pierre PHILIP, MD-PhD
• Phone: +33557820172
• Email: pr.philip[@]free.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 590
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Addiction
• Aging
• Anxiety
• Attention Deficit
• Attention Deficit Disorder With Hyperactivity
• Depression
• Disease
• Parasomnias
• Sleep Disorders

Intervention

Behavioral:
• Clinical interview

• Virtual reality task

Locations

Country	Name	City	State
France	University Hospital of Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University of Bordeaux

Country where clinical trial is conducted

France, 

Outcome

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