Menier's Disease - Bone Density Study

Summary

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.

Conditions

• Meniere Disease
• Osteoporosis
• Osteopenia
• Vitamin D Deficiency
• Vestibular Disorder

Interventions

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

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.

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.

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

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

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

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

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

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

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

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

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.

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.

Sponsors & Collaborators

• HaEmek Medical Center, Israel

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-10-01

Primary Completion

2028-06-30

Completion

2028-12-31