- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07297355
Four Ways to Be Dizzy: When Physiology Fails to Explain Disability Insights From the UVIS International Survey (UVIS)
UVIS - UCLouvain Vertigo International Survey
The aim of this international study is to better understand how vestibular disorders affect daily life, including physical balance, vision and movement tolerance, emotional wellbeing, and cognitive functioning. Vestibular disorders are common but often difficult to diagnose because symptoms vary widely from one patient to another. To improve clinical care, we need large-scale information on the real-world experience of patients across different countries and clinical settings.
The UCLouvain Vertigo International Survey (UVIS) collects standardized information from adults with confirmed vestibular disorders, including questionnaires about dizziness-related handicap, emotional symptoms, and cognitive-vestibular complaints. Ear-nose-throat (ENT) specialists also provide routine clinical test results, such as caloric testing, vestibular evoked myogenic potentials (cVEMP and oVEMP), video head impulse tests (vHIT), and posturography. By combining these data, the study aims to identify different patient profiles and to examine how subjective symptoms relate to the physiological function of the vestibular system.
Participants take part during their routine clinical visit. They complete short questionnaires (on dizziness, anxiety, depression, cognitive symptoms, and daily functioning), and their ENT specialist encodes the results of the vestibular tests already performed as part of their usual care. No additional medical tests are required for the study.
By comparing data from several centers in Belgium, France, and the United States, this project seeks to provide a more complete picture of vestibular disorders worldwide and to support the development of better diagnostic tools and more personalized rehabilitation strategies.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brussels, Belgium
- Cliniques Universitaires Saint-luc
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Marseille, France
- Hôpital Européen Marseille
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
For patients :
Inclusion Criteria:
- Age between 18 and 90 years old.
- Vestibular loss diagnosed by senior ENT doctors
Exclusion Criteria:
- Previous neurological disorders (stroke, dementia, …)
- Current medication interfering with the testing (reducing reaction time).
- Visual difficulties interfering with the testing (Visual field reduction,…)
- Age below 18 years old.
For healthy controls :
Inclusion criteria :
- Age between 18 and 90 years old.
Exclusion criteria:
- Previous neurological disorders (stroke, dementia, …)
- Current medication interfering with the testing (reducing reaction time)
- Visual difficulties interfering with the testing (Visual field reduction,…)
- Vertigo or balance complains or an history of previous vestibular disorder.
- Age below 18 years old.
- Not being able to understand the consigns of the task.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Vestibular
Patients with vestibular loss diagnosed by senior ENT doctors with the gold standard ENT measures (caloric testing, head impulse test and/or vestibular evoked myogenic potential, ocular and cervical)
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Healthy controls
People with no vestibular loss
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Assessment of dizziness-related handicap
Time Frame: Through the entire study, approximately 36 months.
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DHI - Dizziness Handicap Inventory (25 items; physical, functional, emotional subscales).
Scores 0-100.
Higher scores = greater handicap.
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Through the entire study, approximately 36 months.
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Assessment of emotional symptoms
Time Frame: Through the entire study, approximately 36 months.
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HADS - Hospital Anxiety and Depression Scale (14 items; Anxiety and Depression subscales).
Scores 0-21 per subscale.
Higher scores = more symptoms
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Through the entire study, approximately 36 months.
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Assessment of cognitive-vestibular complaints
Time Frame: Through the entire study, approximately 36 months.
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NVI - Neuropsychological Vertigo Inventory (22 items assessing cognitive-vestibular symptoms: attention, memory, spatial orientation, visuospatial abilities).
Higher scores = more complaints
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Through the entire study, approximately 36 months.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Vestibular Physiological Function - canal paresis percentage
Time Frame: Through the entire study, approximately 36 months.
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Through the entire study, approximately 36 months.
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Vestibular Physiological Function - cVEMP and oVEMP
Time Frame: Through the entire study, approximately 36 months.
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Through the entire study, approximately 36 months.
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Vestibular Physiological Function - video Head Impulse Test
Time Frame: Through the entire study, approximately 36 months.
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Through the entire study, approximately 36 months.
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Vestibular Physiological Function - Posturography
Time Frame: Through the entire study, approximately 36 months.
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Through the entire study, approximately 36 months.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABMA-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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