NCT02544295

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
590

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

7 years

First QC Date

September 3, 2015

Last Update Submit

September 8, 2015

Conditions

AgingAddictionAttention Deficit Disorder With HyperactivitySleep DisordersAnxietyDepressionAttention Deficit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Sleepiness scale

    1 day

  • BDI-II questionnaire

    1 day

  • IDS-R questionnaire

    1 day

  • Acceptability scale

    1 day

  • ASRS

    1 day

  • +3 more secondary outcomes

Study Arms (2)

Clinical interview-Virtual reality task:1

EXPERIMENTAL

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 interviewBehavioral: Virtual reality task

Clinical interview-Virtual reality task:2

EXPERIMENTAL

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 interviewBehavioral: Virtual reality task

Interventions

Clinical interviewBEHAVIORAL
Clinical interview-Virtual reality task:1Clinical interview-Virtual reality task:2
Virtual reality taskBEHAVIORAL
Clinical interview-Virtual reality task:1Clinical interview-Virtual reality task:2

Eligibility Criteria

Age7 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being aged between 7 and 75 years
  • Having signed written informed consent

You may not qualify if:

  • Having participated to a clinical trial in the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Bordeaux

Bordeaux, 33076, France

RECRUITING

MeSH Terms

Conditions

Behavior, AddictiveAttention Deficit Disorder with HyperactivitySleep Wake DisordersAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehaviorAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral Symptoms

Study Officials

  • Pierre PHILIP, PhD

    University of Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre PHILIP, MD-PhD

CONTACT

+33557820172pr.philip@free.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD / PhD

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 9, 2015

Study Start

January 1, 2012

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

September 9, 2015

Record last verified: 2015-09

Locations

FR(1)