xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06017466</url>
    </required_header>
    <id_info>
      <org_study_id>22493VVAS</org_study_id>
      <nct_id>NCT06017466</nct_id>
    </id_info>
    <brief_title>Translation and Implementation of the Dutch VVAS Score in Clinical Practice</brief_title>
    <official_title>Translation and Implementation of the Dutch VVAS Score in Clinical Practice</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitair Ziekenhuis Brussel</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitair Ziekenhuis Brussel</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to translate and introduce a cross-cultural adaptation of The Visual&#xD;
        Vertigo Analogue Scale (VVAS). E. Dannenbaum et al developed the VVAS in order to diagnose&#xD;
        visual vertigo (VV). VV is dizziness caused by visual stimuli such as scrolling through a&#xD;
        computer screen or walking through crowds of people or supermarket aisles.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Visual Vertigo Analogue Scale (VVAS) was developed by E. Dannenbaum et al in 2011 to&#xD;
        diagnose visual vertigo. It is a nine-item analogue scale in which the subjects can rate&#xD;
        their symptoms' intensity. The symptoms can be categorized as None (0), Mild (0.1-40),&#xD;
        Moderate (40.01-70), or Severe (70.01-100). The VVAS is already available in English and&#xD;
        French but a Dutch version does not yet exist. In this study, we would like to translate and&#xD;
        introduce a cross-cultural adaptation of the VVAS into Dutch for use with vestibular patients&#xD;
        in Belgium.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>This will be a prospective interventional study with the Dutch VVAS questionnaire as interventional product.</intervention_model_description>
      <primary_purpose>Device Feasibility</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>vertigo symptoms assessed by the visual analogue scale</measure>
      <time_frame>1 year</time_frame>
      <description>Unit of measurement: score from 1 to 10 measurement tool: VVAS questionnaire</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Vertigo</condition>
    <arm_group>
      <arm_group_label>Chronic Vertigo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Visual Vertigo Analogue Scale (VVAS)</intervention_name>
      <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.</description>
      <arm_group_label>Chronic Vertigo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patient with chronic vertigo (&gt;3 years) will included&#xD;
  &#xD;
            -  Interpretation of the VVAS is be possible&#xD;
  &#xD;
            -  18-75 year&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to read Dutch&#xD;
  &#xD;
            -  Single episode of vertigo&#xD;
  &#xD;
            -  &gt; 75 year&#xD;
  &#xD;
            -  Minors&#xD;
  &#xD;
            -  When no interpretation of the VVAS is possible (e.g. too young, dementia)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Marie Reynders, MD</last_name>
      <phone>+32477261213</phone>
      <email>marie.reynders@uzbrussel.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Vedat Topsakal, Prof, MD</last_name>
      <phone>1926881</phone>
      <email>vedat.topsakal@uzbrussel.be</email>
    </overall_contact_backup>
    <verification_date>December 2022</verification_date>
    <study_first_submitted>March 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Vertigo</keyword>
    <keyword>Epidemiology</keyword>
    <keyword>Visually Induced Dizziness</keyword>
    <keyword>Chronic Vertigo</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vertigo</mesh_term>
      <mesh_term>Dizziness</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06017466
  org study id: 22493VVAS
  nct id: NCT06017466
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: This will be a prospective interventional study with the Dutch VVAS questionnaire as interventional product.
  primary purpose: Device Feasibility
  masking: None (Open Label)
  measure: vertigo symptoms assessed by the visual analogue scale
  time frame: 1 year
  description: Unit of measurement: score from 1 to 10 measurement tool: VVAS questionnaire
  arm group label: Chronic Vertigo
  arm group type: Experimental
  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: Visual Vertigo Analogue Scale (VVAS)
  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.
  arm group label: Chronic Vertigo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Marie Reynders, MD
  phone: +32477261213
  email: marie.reynders@uzbrussel.be
  last name: Vedat Topsakal, Prof, MD
  phone: 1926881
  email: vedat.topsakal@uzbrussel.be
  responsible party type: Sponsor
  mesh term: Vertigo
  mesh term: Dizziness