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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02544295
Acronym
PHENOVIRTPSY
Enrollment
590
Registered
2015-09-09
Start date
2012-01-31
Completion date
2019-01-31
Last updated
2015-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

Sponsors

University of Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Presence or absence of the disease1 dayCategorial diagnosis generated by the psychiatrist and by the Virtual reality task (0=absence of disease and 1 = presence of the disease)

Secondary

MeasureTime frameDescription
Sleepiness scale1 dayScores range from 0 (no sleepiness) to 24 (severe sleepiness)
BDI-II questionnaire1 dayBeck Depression Inventory Scores range from 0 (no depression) to 63 (severe depression)
IDS-R questionnaire1 dayInventory of Depressive Symptomatology scores range from 0 (no depression) to 84 (severe depression)
Acceptability scale1 dayScores range from 0 to 36
ASRS1 dayAdult ADHD Self-Report Scale Scores : Four or more positive answers in Part A (6 questions) are indicative of ADHD symptoms.
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

Countries

France

Contacts

Primary ContactPierre PHILIP, MD-PhD
pr.philip@free.fr+33557820172

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026