VertigoMenière09NCT07518069
Genetic and Biohumoral Factors Involved in Menière's Disease and Their Correlation With Phenotypes
An observational study of Vertigo and Meniere's Disease, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vertigo, Meniere's Disease, Vestibular Migraine
- What is being tested?
- a blood withdrawal will be obtained and blood withdrawal
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 9 Apr 2025to 12 Apr 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Patients with definite Menière's Disease according to the criteria of the Barany Society
Who cannot join
- surgically treated before the examination or if they had undergone intratympanic therapy with steroids or gentamicin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele
Milan, Italy, 20132
Roberto Carlo Teggi, MD, +390226432628, teggi.roberto@hsr.it
About this study
Official title: 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
Read the 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.
- Conditions
- Vertigo, Meniere's Disease, Vestibular Migraine
- Being tested
- a blood withdrawal will be obtained, blood withdrawal
- Keywords
- episodic vertigo, Menière's Disease, Vestibular migraine, genetics, biohumoral markers
- Medical subject headings
- Vertigo, Meniere Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a blood withdrawal will be obtainedGenetic
Also called Collection of phenotypes
A blood withdrawal will be obtained to assess
blood withdrawalGenetic
Genetics of ionic transporters and biohumoral factors related to Meniere's Disease and differences with vestibular migraine subjects
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Genetic: a blood withdrawal will be obtained; Genetic: blood withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of enrollment in december 2027
Secondary outcomes (1)
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
Measured: From enrollment to the end of the study in july 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start9 Apr 2025
- Primary completion9 Apr 2027 (estimated)
- Study completion12 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, teggi roberto carlo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518069
- Sponsor's protocol ID
- GO/URC/ER/mm prot 762
- Acronym
- Menière09
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A dataset with genetic data will be shared as a excel file
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics and Biohumoral Factors in Menière's Disease
- ClinicalTrials.gov ID
- NCT07518069
- Acronym / sponsor ID
- Menière09 / GO/URC/ER/mm prot 762
- Conditions
- Vertigo, Meniere's Disease, Vestibular Migraine
- Keywords
- episodic vertigo, Menière's Disease, Vestibular migraine, genetics, biohumoral markers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 9 Apr 2027 (estimated)
- Study completion
- 12 Apr 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Menière's Disease; vestibular migraine | – | Genetic: a blood withdrawal will be obtained, Genetic: blood withdrawalEnrolled 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 |
| Menière's Disease (MD) | – | Genetic: a blood withdrawal will be obtained, Genetic: blood withdrawalTo be included, subjects should fulfill definite diagnostic criteria for MD. A blood withdrawal will be obtained to assess genetic and biohumoral aspects |
| Vestibular Migraine (VM) | – | Genetic: a blood withdrawal will be obtained, Genetic: blood withdrawalTo be included, subjects should fulfill definite diagnostic criteria for VM. A blood withdrawal will be obtained to assess genetic and biohumoral aspects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients with definite Menière's Disease according to the criteria of the Barany Society
Key exclusion criteria (1 listed)
- surgically treated before the examination or if they had undergone intratympanic therapy with steroids or gentamicin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a blood withdrawal will be obtainedAlso: Collection of phenotypesA blood withdrawal will be obtained to assess | Genetic | Menière's Disease (MD), Menière's Disease; vestibular migraine, Vestibular Migraine (VM) |
| blood withdrawalGenetics of ionic transporters and biohumoral factors related to Meniere's Disease and differences with vestibular migraine subjects | Genetic | Menière's Disease (MD), Menière's Disease; vestibular migraine, Vestibular Migraine (VM) |
Primary outcome
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.
1 secondary outcome
Biohumoral factors specifically Interleukins, Endogenous Ouabain
Time frame: From enrollment to the end of the study in july 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Yes. A dataset with genetic data will be shared as a excel file
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertigo and Meniere's Disease, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Carlo Teggi, MD (+393921569410, teggi.roberto@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic of ionic transporters (time frame: From enrollment to the end of enrollment in december 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.