Genetic and Biohumoral Factors Involved in Menière's Disease and Their Correlation With Phenotypes (Menière09)

April 1, 2026 updated by: teggi roberto carlo, IRCCS San Raffaele

Genetics and Biohumoral Factors in Menière's Disease

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Italy
      • Milan, Italy, Italy, 20132
        • Recruiting
        • IRCCS San Raffaele
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients were included if they fulfilled criteria for definite unilateral MD according to the Barany Society; in subjects enrolled before 2015 a retrospective analysis of data confirmed Barany criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Menière's Disease; vestibular migraine
Enrolled subjects should fulfil criteria for definite Menière's Disease (group MD) or definite Vestibular Migraine (VM) according to the ongoing criteria of the Barany Society. Moreover a cohort of non vertiginous subjects will be enrolled. A signed informed consent will be obtained by all subjects. A withdrawal for blood sample will be obtained to study genetic and biohumoral factors in the 3 groups
Genetic: a blood withdrawal will be obtained
A blood withdrawal will be obtained to assess
Other Names:
  • Collection of phenotypes
Genetic: blood withdrawal
Genetics of ionic transporters and biohumoral factors related to Meniere's Disease and differences with vestibular migraine subjects
Menière's Disease (MD)
To be included, subjects should fulfill definite diagnostic criteria for MD. A blood withdrawal will be obtained to assess genetic and biohumoral aspects
Genetic: a blood withdrawal will be obtained
A blood withdrawal will be obtained to assess
Other Names:
  • Collection of phenotypes
Genetic: blood withdrawal
Genetics of ionic transporters and biohumoral factors related to Meniere's Disease and differences with vestibular migraine subjects
Vestibular Migraine (VM)
To be included, subjects should fulfill definite diagnostic criteria for VM. A blood withdrawal will be obtained to assess genetic and biohumoral aspects
Genetic: a blood withdrawal will be obtained
A blood withdrawal will be obtained to assess
Other Names:
  • Collection of phenotypes
Genetic: blood withdrawal
Genetics of ionic transporters and biohumoral factors related to Meniere's Disease and differences with vestibular migraine subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic of ionic transporters
Time Frame: From enrollment to the end of enrollment in december 2027
Genomic DNA of all cases and controls was extracted from venous blood by standard methods. 36 Single Nucleotide Polymorphisms (SNPs) were genotyped using TaqMan® OpenArray™ Genotyping System (Life Technologies, Foster City, CA). All DNA samples were loaded and amplified according to the manufacturer's instructions.
From enrollment to the end of enrollment in december 2027

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biohumoral factors specifically Interleukins, Endogenous Ouabain
Time Frame: From enrollment to the end of the study in july 2027
Values of interleukins and endogenous ouabain is evaluated in blood sample of patients and compared with values in blood samples of a control group and in patients with vestibular migraine
From enrollment to the end of the study in july 2027

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2025

Primary Completion (Estimated)

April 9, 2027

Study Completion (Estimated)

April 12, 2027

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO/URC/ER/mm prot 762

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A dataset with genetic data will be shared as a excel file

IPD Sharing Time Frame

Initial data will be available in december

IPD Sharing Access Criteria

Reviewers for the journal in which the work is submitted. On request, other researchers may access to data

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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