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Completed

NCT Number: NCT03215420

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

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.

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Key information

Conditions

Endolymphatic Hydrops Ear Diseases Labyrinth Diseases Otorhinolaryngologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHu Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI 3T

Diagnostic Test

Primary outcomes

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

    Time frame: day one

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

    Time frame: day one

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

    Time frame: day one

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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)

Acronym: MRI Meniere

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 12, 2017
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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