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

NCT ID: NCT03215420

Last Updated: 2024-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-08

Study Completion Date

2018-10-03

Brief Summary

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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

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Conditions

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Endolymphatic Hydrops

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Certain or probable Meniere's disease

Group Type EXPERIMENTAL

MRI 3T

Intervention Type DIAGNOSTIC_TEST

Interventions

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MRI 3T

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHu Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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DIORFLAR- BOZORG 2016

Identifier Type: -

Identifier Source: org_study_id

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