Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT04987502
Status:
COMPLETED
Last Update Posted:
2025-02-18
First Post:
2021-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality and Subjective Tinnitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2021-07-31', 'studyFirstSubmitQcDate': '2021-07-31', 'lastUpdatePostDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Tinnitus Severity Scale (S.T.S.S.)', 'timeFrame': '5 months', 'description': '16 items multidimensional questionnaire (validated in French) Score 0 to 16 (maximum severity)'}], 'secondaryOutcomes': [{'measure': 'Tinnitus Handicap Questionnaire (THI)', 'timeFrame': '5 months', 'description': '25 items multidimensional questionnaire (validated in French) Score 0 to 100 (maximum handicap)'}, {'measure': 'Hospital Anxiety Depression Scale', 'timeFrame': '5 months', 'description': '14 item questionnaire (validated in French) Score 0 to 21 (maximum anxiety) Score 0 to 21 (maximum depression)'}, {'measure': 'Visual Analog Scale Tinnitus Loudness', 'timeFrame': '5 months', 'description': 'Likert-Scale 0 to 10 (maximum loudness)'}, {'measure': 'Visual Analog Scale Tinnitus Intrusiveness', 'timeFrame': '5 months', 'description': 'Likert-Scale 0 to 10 (maximum intrusiveness)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Subjective tinnitus', 'Virtual Reality', 'Cognitive Behavioral Therapy'], 'conditions': ['Tinnitus', 'Tinnitus, Subjective']}, 'referencesModule': {'references': [{'pmid': '26773752', 'type': 'BACKGROUND', 'citation': 'Malinvaud D, Londero A, Niarra R, Peignard P, Warusfel O, Viaud-Delmon I, Chatellier G, Bonfils P. Auditory and visual 3D virtual reality therapy as a new treatment for chronic subjective tinnitus: Results of a randomized controlled trial. Hear Res. 2016 Mar;333:127-135. doi: 10.1016/j.heares.2015.12.023. Epub 2016 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test if virtual reality immersion has the potential to significantly decrease subjective tinnitus intrusiveness when compared to standard care.', 'detailedDescription': 'This is a randomised controlled study aimed at further validating the use of Virtual Reality in the field of subjective tinnitus management. Indeed, earlier results have suggested that this innovative strategy has the potential to be as efficient as a Cognitive and Behavioural Therapy.\n\nBefore the sessions, an automated tinnitus matching procedure will help create a sound similar to the tinnitus percept ("Tinnitus Avatar").\n\nDuring the sessions (8 sessions; 30 minutes), the "Tinnitus Avatar" will be displayed auditorily but also visually - as a sparkling spot - in a variety of virtual 3D auditory and visual environments.\n\nIn these virtual environments the patients will be given the possibility to voluntarily control and manipulate the "Tinnitus Avatar" by the means of a wand on top of which the sound and the sparkling will be attached. They will also be able to freely navigate in the virtual scenes where environmental sound will be displayed.\n\nThen the patients will be able to displace at will the "Tinnitus Avatar" in their peri-personal space or mask it by getting close to sounds they may encounter in the virtual scenes.\n\nIt is supposed that regaining and training a capacity of interaction with the "Tinnitus Avatar" as if it were a standard sound will help recalibrate the attentional processes involved in tinnitus perception and then to decrease tinnitus intrusiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years and \\< 75 years,\n* French speaking and ability to understand multidimensional questionnaires,\n* Subjective tinnitus of peripheral origin (middle or inner ear auditory nerve)\n* Subjective tinnitus stable and chronic (lasting for more than 6 months)\n* Subjective tinnitus that can be characterized by tinnitus matching\n* Normal hearing or moderate hearing loss\n\nExclusion Criteria:\n\n* Fluctuating tinnitus,\n* Unilateral or bilateral severe or profound hearing loss,\n* Claustrophobia, visual, impairment, vertigo or dizziness, chronic headache or any other condition contraindicating virtual immersion\n* Psychiatric condition requiring immediate management\n* Pregnant or breastfeeding women\n* Protected adults (including individual under guardianship by court order)\n* Persons deprived of their liberty by judicial or administrative decision'}, 'identificationModule': {'nctId': 'NCT04987502', 'acronym': 'ReVA2', 'briefTitle': 'Virtual Reality and Subjective Tinnitus', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Virtual Reality and Subjective Tinnitus', 'orgStudyIdInfo': {'id': 'APHP210808'}, 'secondaryIdInfos': [{'id': '2021-A01045-36', 'type': 'REGISTRY', 'domain': 'ID-RCB Number - ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual reality treatment', 'description': 'Virtual reality immersion with 3D audio and visual rendering (8 weekly sessions)', 'interventionNames': ['Other: Virtual Reality']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment', 'description': 'Counselling Relaxation techniques Sound enrichment', 'interventionNames': ['Behavioral: Standard treatment']}], 'interventions': [{'name': 'Virtual Reality', 'type': 'OTHER', 'description': '8 sessions of virtual reality with 3D audio and visual rendering', 'armGroupLabels': ['Virtual reality treatment']}, {'name': 'Standard treatment', 'type': 'BEHAVIORAL', 'description': 'counselling, relaxation techniques, sound enrichment', 'armGroupLabels': ['Standard treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital européen Georges-Pompidou AP-HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Alain Londero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Two years after the last publication', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared', 'accessCriteria': 'Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered.\n\nData sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement.\n\nProcessing of shared data must comply with European General Data Protection Regulation (GDPR).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut de recherche et de coordination acoustique/musique', 'class': 'UNKNOWN'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'Immersive Therapy', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}