VertigoNCT06017466
Translation and Implementation of the Dutch VVAS Score in Clinical Practice
A study testing Visual Vertigo Analogue Scale (VVAS) in people with Vertigo, run by Universitair Ziekenhuis Brussel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vertigo
- What is being tested?
- Visual Vertigo Analogue Scale (VVAS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patient with chronic vertigo (>3 years) will included
- Interpretation of the VVAS is be possible
- 18-75 year
Who cannot join
- Unable to read Dutch
- Single episode of vertigo
- > 75 year
- Minors
- When no interpretation of the VVAS is possible (e.g. too young, dementia)
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Vertigo
- Being tested
- Visual Vertigo Analogue Scale (VVAS)
- Keywords
- Vertigo, Epidemiology, Visually Induced Dizziness, Chronic Vertigo
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Vertigo Analogue Scale (VVAS)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Vertigo | Experimental | 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. Receives: Diagnostic Test: Visual Vertigo Analogue Scale (VVAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
vertigo symptoms assessed by the visual analogue scale
Unit of measurement: score from 1 to 10 measurement tool: VVAS questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a prospective interventional study with the Dutch VVAS questionnaire as interventional product.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017466
- Sponsor's protocol ID
- 22493VVAS
- Status last verified
- Dec 2022
- First submitted
- 15 Mar 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Implementation of the Dutch VVAS Score in Clinical Practice
- ClinicalTrials.gov ID
- NCT06017466
- Acronym / sponsor ID
- 22493VVAS
- Conditions
- Vertigo
- Keywords
- Vertigo, Epidemiology, Visually Induced Dizziness, Chronic Vertigo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a prospective interventional study with the Dutch VVAS questionnaire as interventional product.
| Arm | Type | Receives |
|---|---|---|
| Chronic Vertigo | Experimental | Diagnostic Test: Visual Vertigo Analogue Scale (VVAS)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patient with chronic vertigo (>3 years) will included
- Interpretation of the VVAS is be possible
- 18-75 year
Key exclusion criteria (5 listed)
- Unable to read Dutch
- Single episode of vertigo
- > 75 year
- Minors
- When no interpretation of the VVAS is possible (e.g. too young, dementia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual Vertigo Analogue Scale (VVAS)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. | Diagnostic test | Chronic Vertigo |
Primary outcome
vertigo symptoms assessed by the visual analogue scale
Time frame: 1 year
Unit of measurement: score from 1 to 10 measurement tool: VVAS questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Vertigo Analogue Scale (VVAS) in people with Vertigo, run by Universitair Ziekenhuis Brussel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Reynders, MD (+32477261213, marie.reynders@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vertigo symptoms assessed by the visual analogue scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.