NCT06017466

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

August 30, 2023

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

March 15, 2023

Last Update Submit

August 24, 2023

Conditions

Keywords

VertigoEpidemiologyVisually Induced DizzinessChronic Vertigo

Outcome Measures

Primary Outcomes (1)

  • vertigo symptoms assessed by the visual analogue scale

    Unit of measurement: score from 1 to 10 measurement tool: VVAS questionnaire

    1 year

Study Arms (1)

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.

Diagnostic Test: Visual Vertigo Analogue Scale (VVAS)

Interventions

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.

Chronic Vertigo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patient with chronic vertigo (\>3 years) will included
  • Interpretation of the VVAS is be possible
  • year

You may not qualify if:

  • Unable to read Dutch
  • Single episode of vertigo
  • \> 75 year
  • Minors
  • When no interpretation of the VVAS is possible (e.g. too young, dementia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Vedat Topsakal, Prof, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: This will be a prospective interventional study with the Dutch VVAS questionnaire as interventional product.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2023

First Posted

August 30, 2023

Study Start

October 1, 2023

Primary Completion

January 1, 2024

Study Completion

March 1, 2024

Last Updated

August 30, 2023

Record last verified: 2022-12