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Translation and Implementation of the Dutch VVAS Score in Clinical Practice

Primary Purpose

Vertigo

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Visual Vertigo Analogue Scale (VVAS)
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Vertigo focused on measuring Vertigo, Epidemiology, Visually Induced Dizziness, Chronic Vertigo

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patient with chronic vertigo (>3 years) will included Interpretation of the VVAS is be possible 18-75 year Exclusion Criteria: Unable to read Dutch Single episode of vertigo > 75 year Minors When no interpretation of the VVAS is possible (e.g. too young, dementia)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Chronic Vertigo

    Arm 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.

    Outcomes

    Primary Outcome Measures

    vertigo symptoms assessed by the visual analogue scale
    Unit of measurement: score from 1 to 10 measurement tool: VVAS questionnaire

    Secondary Outcome Measures

    Full Information

    First Posted
    March 15, 2023
    Last Updated
    August 24, 2023
    Sponsor
    Universitair Ziekenhuis Brussel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06017466
    Brief Title
    Translation and Implementation of the Dutch VVAS Score in Clinical Practice
    Official Title
    Translation and Implementation of the Dutch VVAS Score in Clinical Practice
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    March 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universitair Ziekenhuis Brussel

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vertigo
    Keywords
    Vertigo, Epidemiology, Visually Induced Dizziness, Chronic Vertigo

    7. Study Design

    Primary Purpose
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    This will be a prospective interventional study with the Dutch VVAS questionnaire as interventional product.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Chronic Vertigo
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Visual Vertigo Analogue Scale (VVAS)
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    vertigo symptoms assessed by the visual analogue scale
    Description
    Unit of measurement: score from 1 to 10 measurement tool: VVAS questionnaire
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patient with chronic vertigo (>3 years) will included Interpretation of the VVAS is be possible 18-75 year Exclusion Criteria: Unable to read Dutch Single episode of vertigo > 75 year Minors When no interpretation of the VVAS is possible (e.g. too young, dementia)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marie Reynders, MD
    Phone
    +32477261213
    Email
    marie.reynders@uzbrussel.be
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vedat Topsakal, Prof, MD
    Phone
    1926881
    Email
    vedat.topsakal@uzbrussel.be

    12. IPD Sharing Statement

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    Translation and Implementation of the Dutch VVAS Score in Clinical Practice

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