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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

October 1, 2022

Primary Completion (Anticipated)

June 30, 2028

Study Completion (Anticipated)

December 31, 2028

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

April 3, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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