- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06017466
Translation and Implementation of the Dutch VVAS Score in Clinical Practice
August 24, 2023 updated by: Universitair Ziekenhuis Brussel
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marie Reynders, MD
- Phone Number: +32477261213
- Email: marie.reynders@uzbrussel.be
Study Contact Backup
- Name: Vedat Topsakal, Prof, MD
- Phone Number: 1926881
- Email: vedat.topsakal@uzbrussel.be
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chronic Vertigo
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
vertigo symptoms assessed by the visual analogue scale
Time Frame: 1 year
|
Unit of measurement: score from 1 to 10 measurement tool: VVAS questionnaire
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2023
Primary Completion (Estimated)
January 1, 2024
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
March 15, 2023
First Submitted That Met QC Criteria
August 24, 2023
First Posted (Actual)
August 30, 2023
Study Record Updates
Last Update Posted (Actual)
August 30, 2023
Last Update Submitted That Met QC Criteria
August 24, 2023
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22493VVAS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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