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

Primary Purpose

Aging, Addiction, Attention Deficit Disorder With Hyperactivity

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical interview
Virtual reality task
Sponsored by
University of Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Aging

Eligibility Criteria

7 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital of BordeauxRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Clinical interview-Virtual reality task:1

Clinical interview-Virtual reality task:2

Arm Description

Healthy controls will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration

Patients will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Sleepiness scale
Scores range from 0 (no sleepiness) to 24 (severe sleepiness)
BDI-II questionnaire
Beck Depression Inventory Scores range from 0 (no depression) to 63 (severe depression)
IDS-R questionnaire
Inventory of Depressive Symptomatology scores range from 0 (no depression) to 84 (severe depression)
Acceptability scale
Scores range from 0 to 36
ASRS
Adult 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))
Physiological parameters: Polysomnography (sleep structure (stage %))
Physiological parameters: Polysomnography (Apnea/Hypopnea index and Periodic movements index (events/hr))

Full Information

First Posted
September 3, 2015
Last Updated
September 8, 2015
Sponsor
University of Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT02544295
Brief Title
Based-virtual Reality Diagnosis for Neuropsychiatric Diseases and Sleep/Wake Disorders
Acronym
PHENOVIRTPSY
Official Title
Based-virtual Reality Diagnosis for Neuropsychiatric Diseases and Sleep/Wake Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Addiction, Attention Deficit Disorder With Hyperactivity, Sleep Disorders, Anxiety, Depression, Attention Deficit

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
590 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinical interview-Virtual reality task:1
Arm Type
Experimental
Arm Description
Healthy controls will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration
Arm Title
Clinical interview-Virtual reality task:2
Arm Type
Experimental
Arm Description
Patients will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration
Intervention Type
Behavioral
Intervention Name(s)
Clinical interview
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality task
Primary Outcome Measure Information:
Title
Presence or absence of the disease
Description
Categorial diagnosis generated by the psychiatrist and by the Virtual reality task (0=absence of disease and 1 = presence of the disease)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Sleepiness scale
Description
Scores range from 0 (no sleepiness) to 24 (severe sleepiness)
Time Frame
1 day
Title
BDI-II questionnaire
Description
Beck Depression Inventory Scores range from 0 (no depression) to 63 (severe depression)
Time Frame
1 day
Title
IDS-R questionnaire
Description
Inventory of Depressive Symptomatology scores range from 0 (no depression) to 84 (severe depression)
Time Frame
1 day
Title
Acceptability scale
Description
Scores range from 0 to 36
Time Frame
1 day
Title
ASRS
Description
Adult ADHD Self-Report Scale Scores : Four or more positive answers in Part A (6 questions) are indicative of ADHD symptoms.
Time Frame
1 day
Title
Physiological parameters: Polysomnography (total sleep time (min))
Time Frame
1 night
Title
Physiological parameters: Polysomnography (sleep structure (stage %))
Time Frame
1 night
Title
Physiological parameters: Polysomnography (Apnea/Hypopnea index and Periodic movements index (events/hr))
Time Frame
1 night

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre PHILIP, MD-PhD
Phone
+33557820172
Email
pr.philip@free.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre PHILIP, PhD
Organizational Affiliation
University of Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre PHILIP, MD-PhD
Phone
+33557820172
Email
pr.philip@free.fr

12. IPD Sharing Statement

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

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