Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-04-15 @ 11:08 PM
Study NCT ID:
NCT02544295
Status:
UNKNOWN
Last Update Posted:
2015-09-09
First Post:
2015-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Based-virtual Reality Diagnosis for Neuropsychiatric Diseases and Sleep/Wake Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 590}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-08', 'studyFirstSubmitDate': '2015-09-03', 'studyFirstSubmitQcDate': '2015-09-08', 'lastUpdatePostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence or absence of the disease', 'timeFrame': '1 day', 'description': 'Categorial diagnosis generated by the psychiatrist and by the Virtual reality task (0=absence of disease and 1 = presence of the disease)'}], 'secondaryOutcomes': [{'measure': 'Sleepiness scale', 'timeFrame': '1 day', 'description': 'Scores range from 0 (no sleepiness) to 24 (severe sleepiness)'}, {'measure': 'BDI-II questionnaire', 'timeFrame': '1 day', 'description': 'Beck Depression Inventory Scores range from 0 (no depression) to 63 (severe depression)'}, {'measure': 'IDS-R questionnaire', 'timeFrame': '1 day', 'description': 'Inventory of Depressive Symptomatology scores range from 0 (no depression) to 84 (severe depression)'}, {'measure': 'Acceptability scale', 'timeFrame': '1 day', 'description': 'Scores range from 0 to 36'}, {'measure': 'ASRS', 'timeFrame': '1 day', 'description': 'Adult ADHD Self-Report Scale Scores : Four or more positive answers in Part A (6 questions) are indicative of ADHD symptoms.'}, {'measure': 'Physiological parameters: Polysomnography (total sleep time (min))', 'timeFrame': '1 night'}, {'measure': 'Physiological parameters: Polysomnography (sleep structure (stage %))', 'timeFrame': '1 night'}, {'measure': 'Physiological parameters: Polysomnography (Apnea/Hypopnea index and Periodic movements index (events/hr))', 'timeFrame': '1 night'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aging', 'Addiction', 'Attention Deficit Disorder With Hyperactivity', 'Sleep Disorders', 'Anxiety', 'Depression', 'Attention Deficit']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nType of trial: Comparison of two parallel groups of healthy volunteers and patients with attention disorders, addictive, anxious, depressive or interfering with sleep/wake cycle.\n\nStudy design:\n\n* standardized clinical interview with a sleep specialist, psychiatrist, or psychologist and rating scales,\n* 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).\n\nThe secondary outcomes are:\n\n* The comparison of healthy subjects and patients performances\n* Tolerance, acceptability to exposure to virtual scenarios.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being aged between 7 and 75 years\n* Having signed written informed consent\n\nExclusion Criteria:\n\n* Having participated to a clinical trial in the previous 3 months'}, 'identificationModule': {'nctId': 'NCT02544295', 'acronym': 'PHENOVIRTPSY', 'briefTitle': 'Based-virtual Reality Diagnosis for Neuropsychiatric Diseases and Sleep/Wake Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University of Bordeaux'}, 'officialTitle': 'Based-virtual Reality Diagnosis for Neuropsychiatric Diseases and Sleep/Wake Disorders', 'orgStudyIdInfo': {'id': 'UBXS 2011-02'}, 'secondaryIdInfos': [{'id': '2011-A01418-33', 'type': 'REGISTRY', 'domain': 'ID-RCB/EUDRACT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinical interview-Virtual reality task:1', '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', 'interventionNames': ['Behavioral: Clinical interview', 'Behavioral: Virtual reality task']}, {'type': 'EXPERIMENTAL', 'label': 'Clinical interview-Virtual reality task:2', 'description': 'Patients will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration', 'interventionNames': ['Behavioral: Clinical interview', 'Behavioral: Virtual reality task']}], 'interventions': [{'name': 'Clinical interview', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Clinical interview-Virtual reality task:1', 'Clinical interview-Virtual reality task:2']}, {'name': 'Virtual reality task', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Clinical interview-Virtual reality task:1', 'Clinical interview-Virtual reality task:2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre PHILIP, MD-PhD', 'role': 'CONTACT', 'email': 'pr.philip@free.fr', 'phone': '+33557820172'}], 'facility': 'University Hospital of Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'centralContacts': [{'name': 'Pierre PHILIP, MD-PhD', 'role': 'CONTACT', 'email': 'pr.philip@free.fr', 'phone': '+33557820172'}], 'overallOfficials': [{'name': 'Pierre PHILIP, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD / PhD', 'investigatorFullName': 'Pierre Philip', 'investigatorAffiliation': 'University of Bordeaux'}}}}