- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02544295
Based-virtual Reality Diagnosis for Neuropsychiatric Diseases and Sleep/Wake Disorders (PHENOVIRTPSY)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pierre PHILIP, MD-PhD
- Phone Number: +33557820172
- Email: pr.philip@free.fr
Study Locations
-
-
-
Bordeaux, France, 33076
- Recruiting
- University Hospital of Bordeaux
-
Contact:
- Pierre PHILIP, MD-PhD
- Phone Number: +33557820172
- Email: pr.philip@free.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Clinical interview-Virtual reality task:1
Healthy controls will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration
|
|
Experimental: Clinical interview-Virtual reality task:2
Patients will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence or absence of the disease
Time Frame: 1 day
|
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
Time Frame: 1 day
|
Scores range from 0 (no sleepiness) to 24 (severe sleepiness)
|
1 day
|
BDI-II questionnaire
Time Frame: 1 day
|
Beck Depression Inventory Scores range from 0 (no depression) to 63 (severe depression)
|
1 day
|
IDS-R questionnaire
Time Frame: 1 day
|
Inventory of Depressive Symptomatology scores range from 0 (no depression) to 84 (severe depression)
|
1 day
|
Acceptability scale
Time Frame: 1 day
|
Scores range from 0 to 36
|
1 day
|
ASRS
Time Frame: 1 day
|
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))
Time Frame: 1 night
|
1 night
|
|
Physiological parameters: Polysomnography (sleep structure (stage %))
Time Frame: 1 night
|
1 night
|
|
Physiological parameters: Polysomnography (Apnea/Hypopnea index and Periodic movements index (events/hr))
Time Frame: 1 night
|
1 night
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre PHILIP, PhD, University of Bordeaux
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UBXS 2011-02
- 2011-A01418-33 (Registry Identifier: ID-RCB/EUDRACT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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