An observational study in Vertigo, Meniere's Disease and Vestibular Migraine, sponsored by IRCCS San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by IRCCS San Raffaele · Observational
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
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.
187 studies on the registry are indexed under Vertigo; 27 are open to participants now.
This study's planned enrollment of 250 is above the median of 198 across 42 observational studies indexed under Vertigo.
Browse Vertigo studies →IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.
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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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
A blood withdrawal will be obtained to assess
Also known as: Collection of phenotypes
Genetics of ionic transporters and biohumoral factors related to Meniere's Disease and differences with vestibular migraine subjects
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.
Time frame: From enrollment to the end of enrollment in december 2027
Biohumoral factors specifically Interleukins, Endogenous Ouabain
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
Time frame: From enrollment to the end of the study in july 2027
Plan to share: Yes — A dataset with genetic data will be shared as a excel file
Supporting information: Clinical study report
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
Data sharing details ↗ · hsr.it
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Started Apr 2025 (actual). Primary completion is estimated for Apr 2027, 24 months after the start.
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