Diagnostic Agreement of Electrophysiological Audiovestibular Examinations With Magnetic Resonance Imaging (MRI) of the Inner Ear in Revealing Endolymphatic Hydrops (EH) in Patients With Certain or Probable Meniere's Disease (MD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Number of patients for whom an endolymphatic hydrops was diagnosed by electrocochleography
研究概览
简要总结
The aim of this study is to compare 3 methods for the diagnosis of endolymphatic hydrops (EH) in patients with Meniere's disease: MRI 3 Tesla (to visualise EH directly), and functional explorations, namely electrocochleography and dephasing of acoustic distortion products (which are modified by the EH).
The research hypothesis is that the examinations will show agreement in the diagnosis of EH, and that the results obtained (quantitative values) will vary in the same direction over time and during flares of MD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •persons who have provided written consent
- •persons aged 18 to 75 years
- •persons with certain, probable or possible Meniere's disease according to the international classification AAO-HNS
排除标准
- •persons without health insurance cover
- •adults under guardianship
- •persons with a history of hypersensitivity to the active substance or to one of the excipients of the contrast agent used for the MRI or to any gadolinium chelate
- •pregnant or breast-feeding women
- •severe acute or chronic kidney failure
- •other identified causes of cochleo-vestibular syndromes
- •Impossibility to follow-up or carry out any of the examinations necessary for the protocol
研究组 & 干预措施
Certain or probable Meniere's disease
干预措施: MRI 3T (Diagnostic Test)
结局指标
主要结局
Number of patients for whom an endolymphatic hydrops was diagnosed by electrocochleography
时间窗: day one
Number of patients for whom an endolymphatic hydrops was diagnosed by (Dephasing) of acoustic distortion products
时间窗: day one
Number of patients for whom an endolymphatic hydrops was diagnosed by 3T MRI 3T
时间窗: day one
次要结局
未报告次要终点