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临床试验/NCT07297355
NCT07297355已完成不适用

UVIS - UCLouvain Vertigo International Survey

Université Catholique de Louvain3 个研究点 分布在 3 个国家目标入组 250 人开始时间: 2023年11月10日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
3
主要终点
Assessment of dizziness-related handicap

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 90 years old.
  • Vestibular loss diagnosed by senior ENT doctors

排除标准

  • 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.

结局指标

主要结局

Assessment of dizziness-related handicap

时间窗: Through the entire study, approximately 36 months.

DHI - Dizziness Handicap Inventory (25 items; physical, functional, emotional subscales). Scores 0-100. Higher scores = greater handicap.

Assessment of emotional symptoms

时间窗: Through the entire study, approximately 36 months.

HADS - Hospital Anxiety and Depression Scale (14 items; Anxiety and Depression subscales). Scores 0-21 per subscale. Higher scores = more symptoms

Assessment of cognitive-vestibular complaints

时间窗: Through the entire study, approximately 36 months.

NVI - Neuropsychological Vertigo Inventory (22 items assessing cognitive-vestibular symptoms: attention, memory, spatial orientation, visuospatial abilities). Higher scores = more complaints

次要结局

  • Vestibular Physiological Function - cVEMP and oVEMP(Through the entire study, approximately 36 months.)
  • Vestibular Physiological Function - video Head Impulse Test(Through the entire study, approximately 36 months.)
  • Vestibular Physiological Function - canal paresis percentage(Through the entire study, approximately 36 months.)
  • Vestibular Physiological Function - Posturography(Through the entire study, approximately 36 months.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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