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

NCT07518069 | Recruiting DMC

• 1 other identifier: GO/URC/ER/mm prot 762
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vestibular Migraine; Vertigo; Meniere's Disease

Keywords

episodic vertigo; Menière's Disease; Vestibular migraine; genetics; biohumoral markers

Outcome Measures

Primary Outcomes (1)

• Genetic of ionic transporters

  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 Outcomes (1)

• Biohumoral factors specifically Interleukins, Endogenous Ouabain

  From enrollment to the end of the study in july 2027

Study Arms (3)

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; Genetic: blood withdrawal

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; Genetic: blood withdrawal

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; Genetic: blood withdrawal

Interventions

a blood withdrawal will be obtained GENETIC

A blood withdrawal will be obtained to assess

Also known as: Collection of phenotypes

Menière's Disease (MD); Menière's Disease; vestibular migraine; Vestibular Migraine (VM)

blood withdrawal GENETIC

Genetics of ionic transporters and biohumoral factors related to Meniere's Disease and differences with vestibular migraine subjects

Menière's Disease (MD); Menière's Disease; vestibular migraine; Vestibular Migraine (VM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, Italy, 20132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A blood sample for each subject will be retained

MeSH Terms

Conditions

Vertigo; Meniere Disease

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endolymphatic Hydrops

Central Study Contacts

Roberto Carlo Teggi, MD

CONTACT

+393921569410; teggi.roberto@hsr.it

Laura Zagato, MD

CONTACT

+393406133818; zagato.laura@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant for vestibular disorders

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: April 9, 2025
• Primary Completion (Estimated): April 9, 2027
• Study Completion (Estimated): April 12, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Initial data will be available in december
• Access Criteria: Reviewers for the journal in which the work is submitted. On request, other researchers may access to data

Locations

IT (1)