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

Study Overview
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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.

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

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

Intervention / Treatment
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* Behavioral: Clinical interview
* Behavioral: Virtual reality task


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical interview-Virtual reality task:1<br>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<br> <br> Behavioral: Virtual reality task<br> <br> |
| Experimental: Clinical interview-Virtual reality task:2<br>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<br> <br> Behavioral: Virtual reality task<br> <br> |

What is the study measuring?
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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 |