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

Not Applicable

Completed

• Conditions: Endolymphatic Hydrops
• Interventions: Diagnostic Test: MRI 3T

• Registration Number: NCT03215420
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-08
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-12
• Primary Completion: 2018-07-03
• Study Completion: 2018-10-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Certain or probable Meniere's disease	MRI 3T	-

Primary Outcome Measures

Name	Time	Method
Number of patients for whom an endolymphatic hydrops was diagnosed by electrocochleography	day one
Number of patients for whom an endolymphatic hydrops was diagnosed by (Dephasing) of acoustic distortion products	day one
Number of patients for whom an endolymphatic hydrops was diagnosed by 3T MRI 3T	day one

Trial Locations

Locations (1)

CHu Dijon Bourgogne; 🇫🇷 Dijon, France