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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01418-33 | Registry Identifier | ID-RCB/EUDRACT |
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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.
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:
The secondary outcomes are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical interview | Behavioral |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleepiness scale | Scores range from 0 (no sleepiness) to 24 (severe sleepiness) | 1 day |
| BDI-II questionnaire | Beck Depression Inventory Scores range from 0 (no depression) to 63 (severe depression) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre PHILIP, MD-PhD | Contact | +33557820172 | pr.philip@free.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre PHILIP, PhD | University of Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Bordeaux | Recruiting | Bordeaux | 33076 | France |
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| ID | Term |
|---|---|
| D016739 | Behavior, Addictive |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D012893 | Sleep Wake Disorders |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
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| Virtual reality task |
| Behavioral |
|
| 1 day |
| IDS-R questionnaire | Inventory of Depressive Symptomatology scores range from 0 (no depression) to 84 (severe depression) | 1 day |
| Acceptability scale | Scores range from 0 to 36 | 1 day |
| ASRS | 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)) | 1 night |
| Physiological parameters: Polysomnography (sleep structure (stage %)) | 1 night |
| Physiological parameters: Polysomnography (Apnea/Hypopnea index and Periodic movements index (events/hr)) | 1 night |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |