Based-virtual Reality Diagnosis for Neuropsychiatric Diseases and Sleep/Wake Disorders
- Conditions
- AddictionAgingAttention DeficitAttention Deficit Disorder With HyperactivitySleep DisordersAnxietyDepression
- Interventions
- Behavioral: Clinical interviewBehavioral: Virtual reality task
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 590
- Being aged between 7 and 75 years
- Having signed written informed consent
- Having participated to a clinical trial in the previous 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clinical interview-Virtual reality task:1 Virtual reality task Healthy controls will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration Clinical interview-Virtual reality task:2 Virtual reality task Patients will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration Clinical interview-Virtual reality task:1 Clinical interview Healthy controls will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration Clinical interview-Virtual reality task:2 Clinical interview Patients will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration
- 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 Sleepiness scale 1 day Scores range from 0 (no sleepiness) to 24 (severe sleepiness)
BDI-II questionnaire 1 day Beck Depression Inventory Scores range from 0 (no depression) to 63 (severe depression)
Physiological parameters: Polysomnography (sleep structure (stage %)) 1 night 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.
Trial Locations
- Locations (1)
University Hospital of Bordeaux
🇫🇷Bordeaux, France