Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT06017466
Status:
UNKNOWN
Last Update Posted:
2023-08-30
First Post:
2023-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Translation and Implementation of the Dutch VVAS Score in Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014717', 'term': 'Vertigo'}], 'ancestors': [{'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This will be a prospective interventional study with the Dutch VVAS questionnaire as interventional product.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-24', 'studyFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2023-08-24', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vertigo symptoms assessed by the visual analogue scale', 'timeFrame': '1 year', 'description': 'Unit of measurement: score from 1 to 10 measurement tool: VVAS questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vertigo', 'Epidemiology', 'Visually Induced Dizziness', 'Chronic Vertigo'], 'conditions': ['Vertigo']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to translate and introduce a cross-cultural adaptation of The Visual Vertigo Analogue Scale (VVAS). E. Dannenbaum et al developed the VVAS in order to diagnose visual vertigo (VV). VV is dizziness caused by visual stimuli such as scrolling through a computer screen or walking through crowds of people or supermarket aisles.', 'detailedDescription': "The Visual Vertigo Analogue Scale (VVAS) was developed by E. Dannenbaum et al in 2011 to diagnose visual vertigo. It is a nine-item analogue scale in which the subjects can rate their symptoms' intensity. The symptoms can be categorized as None (0), Mild (0.1-40), Moderate (40.01-70), or Severe (70.01-100). The VVAS is already available in English and French but a Dutch version does not yet exist. In this study, we would like to translate and introduce a cross-cultural adaptation of the VVAS into Dutch for use with vestibular patients in Belgium."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patient with chronic vertigo (\\>3 years) will included\n* Interpretation of the VVAS is be possible\n* 18-75 year\n\nExclusion Criteria:\n\n* Unable to read Dutch\n* Single episode of vertigo\n* \\> 75 year\n* Minors\n* When no interpretation of the VVAS is possible (e.g. too young, dementia)'}, 'identificationModule': {'nctId': 'NCT06017466', 'briefTitle': 'Translation and Implementation of the Dutch VVAS Score in Clinical Practice', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Translation and Implementation of the Dutch VVAS Score in Clinical Practice', 'orgStudyIdInfo': {'id': '22493VVAS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chronic Vertigo', 'description': "Chronic vertigo patients can be divided into three groups. The first pathway is episodic vertigo (caused by e.g. migraine, Ménière's disease, benign paroxysmal positional vertigo (BPPV)) progressively leading to chronic dizziness. The second pathway is initiated by a single attack of vertigo (e.g. neuritis vestibularis) with some initial recovery but later on residual symptoms. The third pathway is the presence of chronic, slowly progressive, continuous, or unchanging symptoms (e.g. bilateral vestibular failure, CNS disorders). All patient with chronic vertigo (see above) will included.", 'interventionNames': ['Diagnostic Test: Visual Vertigo Analogue Scale (VVAS)']}], 'interventions': [{'name': 'Visual Vertigo Analogue Scale (VVAS)', 'type': 'DIAGNOSTIC_TEST', 'description': 'The Visual Vertigo Analogue Scale (VVAS) was developed by E. Dannenbaum et al in 2011 to diagnose visual vertigo. It is a nine-item analogue scale in which the subjects can rated the intensity of their symptoms. The symptoms can be categorized as None (0), Mild (0.1-40), Moderate (40.01-70) or Severe (70.01-100). The VVAS is already available in English and French but a Dutch version does not yet exist.', 'armGroupLabels': ['Chronic Vertigo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marie Reynders, MD', 'role': 'CONTACT', 'email': 'marie.reynders@uzbrussel.be', 'phone': '+32477261213'}, {'name': 'Vedat Topsakal, Prof, MD', 'role': 'CONTACT', 'email': 'vedat.topsakal@uzbrussel.be', 'phone': '1926881'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}