Comparison of 3 Methods to Diagnose Endolymphatic Hydrops in Meniere's Disease

Centre Hospitalier Universitaire Dijon41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Endolymphatic Hydrops

Interventions

MRI 3TDIAGNOSTIC_TEST

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

CHu Dijon Bourgogne

Dijon, France

Outcomes

Primary Outcomes

Number of patients for whom an endolymphatic hydrops was diagnosed by electrocochleography

Time frame: day one

Number of patients for whom an endolymphatic hydrops was diagnosed by (Dephasing) of acoustic distortion products

Time frame: day one

Number of patients for whom an endolymphatic hydrops was diagnosed by 3T MRI 3T

Time frame: day one

Data from ClinicalTrials.gov

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