Menier's Disease - Bone Density Study

August 2, 2022 updated by: Paker Miki, HaEmek Medical Center, Israel
Meniere's disease is a progressive and debilitating inner ear disease characterised by vertigo and hearing loss. Several studies have linked Menierws disease with lower bone density and lower vitamin D levels. In the current prospective study definite Meniere's patients will be followed over a period of 2 year, during which repetitive measurements of bone density, vitamin D plasma levels, blood pressure as well as hearing and vestibular tests will be made. Results will be compared to healthy controls.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Definite Meniere's disease

Exclusion Criteria:

  • hyperthyroidism
  • hyperparathyroidism
  • acromegaly
  • hypogonadism
  • diabetes melitus
  • chronic renal failure
  • alcoholism
  • cushing syndrome
  • rheumatoid arthritis
  • systemic lupus erythematosus
  • ankylosing spondylitis
  • inflammatory bowel disease
  • obstructive lung disease
  • sarcoidosis
  • amyloidosis
  • celiac disease.
  • chronic treatment with bisphosphonates
  • chronic treatment with glucocorticoids
  • chronic treatment with androgen deprivation therapy
  • chronic treatment with gonadotropin releasing hormone agonist chronic treatment with aromatase inhibitor chronic treatment with loop diuretics chronic treatment with proton pump inhibitors chronic treatment with anti-seizure drugs chronic treatment with warfarin chronic treatment with SSRI chronic treatment with alpha or beta-blockers

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Controls
Healthy controls with no known vestibular disease
Diagnostic test: vitamin D plasma levels baseline
Measuring vitamin D plasma levels at baseline
Diagnostic test: Dual-energy X-ray absorptiometry at baseline
Measuring T-score and Z-score of the femur and lumbar spine at baseline
Other Names:
  • DEXA
Diagnostic test: Measuring Orthostatic Blood Pressure at baseline
blood pressure will be measure two minutes after lying supine and repeated 3 minutes after standing. A drop of at least 20mmHg systolic pressure or at least 10mmHg diastolic blood pressure is considered a positive test
Other Names:
  • Orthostatic Hypotension
Diagnostic test: cold pressor test at baseline
The cold pressor test is an indicator for sympathetic system function. A rise of at least 15mmHg of systolic pressure after putting the subject's hand in cold water (4 deg Celsius) is indicative of normal sympathetic function.
Experimental: Definite Meniere's disease
Patients with Definite Meniere's disease
Diagnostic test: vitamin D plasma levels baseline
Measuring vitamin D plasma levels at baseline
Diagnostic test: Dual-energy X-ray absorptiometry at baseline
Measuring T-score and Z-score of the femur and lumbar spine at baseline
Other Names:
  • DEXA
Diagnostic test: Measuring Orthostatic Blood Pressure at baseline
blood pressure will be measure two minutes after lying supine and repeated 3 minutes after standing. A drop of at least 20mmHg systolic pressure or at least 10mmHg diastolic blood pressure is considered a positive test
Other Names:
  • Orthostatic Hypotension
Diagnostic test: cold pressor test at baseline
The cold pressor test is an indicator for sympathetic system function. A rise of at least 15mmHg of systolic pressure after putting the subject's hand in cold water (4 deg Celsius) is indicative of normal sympathetic function.
Diagnostic test: cervical Vestibular evoked myogenic potentials at baseline
cVEMP is a vestibular test for saccular function, an otolith organ in the inner ear. the electrical response of the stermocledomastoid muscle to saccular stimulation is measured via two distinct waves - P13 and N23. the latency, amplitude and peak to peak amplitude will be measured.
Other Names:
  • cVEMP
Diagnostic test: Audiogram at baseline
hearing measurement will be performed. Hearing level in dB will be performed in the 250-8,000 Hz frequency. The test includes Speech reception threshold and word recognition score.
Other Names:
  • Hearing test
Diagnostic test: vitamin D plasma levels one year after recruitment
Measuring vitamin D plasma levels one year after recruitment
Diagnostic test: vitamin D plasma levels two years after recruitment
Measuring vitamin D plasma levels two years after recruitment
Diagnostic test: Dual-energy X-ray absorptiometry one year after recruitment
Measuring T-score and Z-score of the femur and lumbar spine one year after recruitment
Other Names:
  • DEXA
Diagnostic test: Dual-energy X-ray absorptiometry two years after recruitment
Measuring T-score and Z-score of the femur and lumbar spine two years after recruitment
Diagnostic test: cervical Vestibular evoked myogenic potentials one year after recruitment
cVEMP is a vestibular test for saccular function, an otolith organ in the inner ear. the electrical response of the stermocledomastoid muscle to saccular stimulation is measured via two distinct waves - P13 and N23. the latency, amplitude and peak to peak amplitude will be measured one year after recruitment
Other Names:
  • cVEMP
Diagnostic test: cervical Vestibular evoked myogenic potentials two years after recruitment
cVEMP is a vestibular test for saccular function, an otolith organ in the inner ear. the electrical response of the stermocledomastoid muscle to saccular stimulation is measured via two distinct waves - P13 and N23. the latency, amplitude and peak to peak amplitude will be measured two years after recruitment
Other Names:
  • cVEMP
Diagnostic test: Audiogram one year after recruitment
hearing measurement will be performed. Hearing level in dB will be performed in the 250-8,000 Hz frequency. The test includes Speech reception threshold and word recognition score performed one year after recruitment
Other Names:
  • Hearing test
Diagnostic test: Audiogram two years after recruitment
hearing measurement will be performed. Hearing level in dB will be performed in the 250-8,000 Hz frequency. The test includes Speech reception threshold and word recognition score performed two years after recruitment
Other Names:
  • Hearing test
Diagnostic test: Measuring Orthostatic Blood Pressure one year after recruitment
blood pressure will be measure two minutes after lying supine and repeated 3 minutes after standing. A drop of at least 20mmHg systolic pressure or at least 10mmHg diastolic blood pressure is considered a positive test. The test will be performed one year after recruitment
Other Names:
  • Ortostatic hypostension
Diagnostic test: Measuring Orthostatic Blood Pressure two years after recruitment
blood pressure will be measure two minutes after lying supine and repeated 3 minutes after standing. A drop of at least 20mmHg systolic pressure or at least 10mmHg diastolic blood pressure is considered a positive test. The test will be performed two year after recruitment.
Other Names:
  • Ostostatic hypotension
Diagnostic test: cold pressor test one year after recruitment
The cold pressor test is an indicator for sympathetic system function. A rise of at least 15mmHg of systolic pressure after putting the subject's hand in cold water (4 deg Celsius) is indicative of normal sympathetic function. The test will be performed one year after recruitment.
Diagnostic test: cold pressor test two years after recruitment
The cold pressor test is an indicator for sympathetic system function. A rise of at least 15mmHg of systolic pressure after putting the subject's hand in cold water (4 deg Celsius) is indicative of normal sympathetic function. The test will be performed two years after recruitment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vitamin D plasma levels
Time Frame: baseline
Vitamin D plasma levels
baseline
Vitamin D plasma levels
Time Frame: one year follow up
Vitamin D plasma levels
one year follow up
Vitamin D plasma levels
Time Frame: two years follow-up
Vitamin D plasma levels
two years follow-up
Z-score and T-score of femur and lumbur spine
Time Frame: baseline
DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score
baseline
Z-score and T-score of femur and lumbur spine
Time Frame: one year follow up
DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score
one year follow up
Z-score and T-score of femur and lumbur spine
Time Frame: two years follow-up
DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score
two years follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
positive ortostatic hypotension
Time Frame: baseline
drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive
baseline
positive ortostatic hypotension
Time Frame: one year follow up
drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive
one year follow up
positive ortostatic hypotension
Time Frame: Two years follow-up
drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive
Two years follow-up
cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
Time Frame: baseline
a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function
baseline
cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
Time Frame: one year follow up
a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function
one year follow up
cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
Time Frame: two years follow-up
a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function
two years follow-up
ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
Time Frame: baseline
cervical vestibular evoked myogenic potential exam
baseline
ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
Time Frame: one year follow up
cervical vestibular evoked myogenic potential exam
one year follow up
ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
Time Frame: two years follow-up
cervical vestibular evoked myogenic potential exam
two years follow-up
Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
Time Frame: baseline
audiology exam
baseline
Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
Time Frame: one year follow up
audiology exam
one year follow up
Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
Time Frame: two years follow-up
audiology exam
two years follow-up

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HaEmek Medical Center, Israel

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EMC-22-0031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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