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Recruiting NCT07518069

Genetic and Biohumoral Factors Involved in Menière's Disease and Their Correlation With Phenotypes

Observational Vertigo Meniere's Disease Vestibular Migraine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: a blood withdrawal will be obtained, blood withdrawal.
Who it may be relevant to
Registry conditions: Vertigo, Meniere's Disease, Vestibular Migraine. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Genetics and Biohumoral Factors in Menière's Disease

Overview

Aim of this work was to assess the role of polymorphisms belonging to genes involved in the regulation of ionic homeostasis in Caucasian patients with Ménière Disease (MD) and compare results with a cohort of patients affected by vestibular migraine and a cohort of non vestibular subjects

Detailed description

Ménière's Disease (MD) is an inner ear disorder characterized by episodic vertigo, fluctuating sensorineural hearing loss and aural fullness \[1\]; endolymphatic hydrops is commonly associated with the pathophysiology of the disorder, although current data support the hypothesis that hydrops is an epiphenomenon associated with different inner ear disorders. The frequency of familial cases has been estimated in the range between 5 and 15% and it has been hypothesized that the disorder may arise from the interplay of genetic and environmental factors. Different candidate genes have been studied, although to date genetic investigation produced no conclusive results .

Among others, considering the importance of ionic homeostasis in the inner ear for the maintenance of endocochlear potential, genetic of fluid and ionic homeostasis have been included. A mutation of KCNQ1 and KCNE1 channels, co-expressed in the inner ear and in the heart, leads to a severe sensorineural deafness and a collapse of the cochlear scala media as seen in Jervell and Lange-Nielsen syndrome.

The aim of this work was to assess the role of genetic polymorphisms located in genes involved in the regulation of ionic transport on an Italian population of patients with definite MD.

Interventions

  • Genetic a blood withdrawal will be obtained
    A blood withdrawal will be obtained to assess
  • Genetic blood withdrawal
    Genetics of ionic transporters and biohumoral factors related to Meniere's Disease and differences with vestibular migraine subjects

Primary outcome measures

  • Genetic of ionic transporters [Time frame: From enrollment to the end of enrollment in december 2027]
Secondary outcome measures (1)
  • Biohumoral factors specifically Interleukins, Endogenous Ouabain [Time frame: From enrollment to the end of the study in july 2027]

Eligibility criteria

Inclusion criteria

  • Patients with definite Menière's Disease according to the criteria of the Barany Society

Exclusion criteria

  • surgically treated before the examination or if they had undergone intratympanic therapy with steroids or gentamicin

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Italy · 1 center
  • IRCCS San Raffaele — Milan

Identifiers

NCT: NCT07518069 · GO/URC/ER/mm prot 762

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗