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

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03215420
Acronym
MRI Meniere
Enrollment
41
Registered
2017-07-12
Start date
2016-09-08
Completion date
2018-10-03
Last updated
2024-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endolymphatic Hydrops

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.

Interventions

DIAGNOSTIC_TESTMRI 3T

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of patients for whom an endolymphatic hydrops was diagnosed by electrocochleographyday one
Number of patients for whom an endolymphatic hydrops was diagnosed by (Dephasing) of acoustic distortion productsday one
Number of patients for whom an endolymphatic hydrops was diagnosed by 3T MRI 3Tday one

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026