Menier's Disease - Bone Density Study

Study Overview
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Brief Summary
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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.

Official Title
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Menier's Disease - Bone Density Study

Conditions
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Vitamin D Deficiency, Vestibular Disorder, Meniere Disease, Osteoporosis, Osteopenia

Intervention / Treatment
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* Diagnostic Test: vitamin D plasma levels baseline
* Diagnostic Test: Dual-energy X-ray absorptiometry at baseline
* Diagnostic Test: cervical Vestibular evoked myogenic potentials at baseline
* Diagnostic Test: Audiogram at baseline
* Diagnostic Test: Measuring Orthostatic Blood Pressure at baseline
* Diagnostic Test: cold pressor test at baseline
* Diagnostic Test: vitamin D plasma levels one year after recruitment
* Diagnostic Test: vitamin D plasma levels two years after recruitment
* Diagnostic Test: Dual-energy X-ray absorptiometry one year after recruitment
* Diagnostic Test: Dual-energy X-ray absorptiometry two years after recruitment
* Diagnostic Test: cervical Vestibular evoked myogenic potentials one year after recruitment
* Diagnostic Test: cervical Vestibular evoked myogenic potentials two years after recruitment
* Diagnostic Test: Audiogram one year after recruitment
* Diagnostic Test: Audiogram two years after recruitment
* Diagnostic Test: Measuring Orthostatic Blood Pressure one year after recruitment
* Diagnostic Test: Measuring Orthostatic Blood Pressure two years after recruitment
* Diagnostic Test: cold pressor test one year after recruitment
* Diagnostic Test: cold pressor test two years after recruitment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Controls<br>Healthy controls with no known vestibular disease | Diagnostic Test: vitamin D plasma levels baseline<br>* Measuring vitamin D plasma levels at baseline<br>Diagnostic Test: Dual-energy X-ray absorptiometry at baseline<br>* Measuring T-score and Z-score of the femur and lumbar spine at baseline<br>* Other names: DEXA;Diagnostic Test: Measuring Orthostatic Blood Pressure at baseline<br>* 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<br>* Other names: Orthostatic Hypotension;Diagnostic Test: cold pressor test at baseline<br>* 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.<br>|
| Experimental: Definite Meniere's disease<br>Patients with Definite Meniere's disease | Diagnostic Test: vitamin D plasma levels baseline<br>* Measuring vitamin D plasma levels at baseline<br>Diagnostic Test: Dual-energy X-ray absorptiometry at baseline<br>* Measuring T-score and Z-score of the femur and lumbar spine at baseline<br>* Other names: DEXA;Diagnostic Test: cervical Vestibular evoked myogenic potentials at baseline<br>* 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.<br>* Other names: cVEMP;Diagnostic Test: Audiogram at baseline<br>* 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.<br>* Other names: Hearing test;Diagnostic Test: Measuring Orthostatic Blood Pressure at baseline<br>* 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<br>* Other names: Orthostatic Hypotension;Diagnostic Test: cold pressor test at baseline<br>* 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.<br>Diagnostic Test: vitamin D plasma levels one year after recruitment<br>* Measuring vitamin D plasma levels one year after recruitment<br>Diagnostic Test: vitamin D plasma levels two years after recruitment<br>* Measuring vitamin D plasma levels two years after recruitment<br>Diagnostic Test: Dual-energy X-ray absorptiometry one year after recruitment<br>* Measuring T-score and Z-score of the femur and lumbar spine one year after recruitment<br>* Other names: DEXA;Diagnostic Test: Dual-energy X-ray absorptiometry two years after recruitment<br>* Measuring T-score and Z-score of the femur and lumbar spine two years after recruitment<br>Diagnostic Test: cervical Vestibular evoked myogenic potentials one year after recruitment<br>* 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<br>* Other names: cVEMP;Diagnostic Test: cervical Vestibular evoked myogenic potentials two years after recruitment<br>* 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<br>* Other names: cVEMP;Diagnostic Test: Audiogram one year after recruitment<br>* 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<br>* Other names: Hearing test;Diagnostic Test: Audiogram two years after recruitment<br>* 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<br>* Other names: Hearing test;Diagnostic Test: Measuring Orthostatic Blood Pressure one year after recruitment<br>* 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<br>* Other names: Ortostatic hypostension;Diagnostic Test: Measuring Orthostatic Blood Pressure two years after recruitment<br>* 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.<br>* Other names: Ostostatic hypotension;Diagnostic Test: cold pressor test one year after recruitment<br>* 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.<br>Diagnostic Test: cold pressor test two years after recruitment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D plasma levels | Vitamin D plasma levels | baseline | 
| Vitamin D plasma levels | Vitamin D plasma levels | one year follow up | 
| Vitamin D plasma levels | Vitamin D plasma levels | two years follow-up | 
| Z-score and T-score of femur and lumbur spine | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | cervical vestibular evoked myogenic potential exam | baseline | 
| ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test | 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 | cervical vestibular evoked myogenic potential exam | two years follow-up | 
| Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam | audiology exam | baseline | 
| Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam | audiology exam | one year follow up | 
| Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam | audiology exam | two years follow-up |