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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controls | Other | Healthy controls with no known vestibular disease |
|
| Definite Meniere's disease | Experimental | Patients with Definite Meniere's disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D plasma levels baseline | Diagnostic Test | Measuring vitamin D plasma levels at baseline |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoni Evgeni Gutkovich, M.D\Ph.D | Contact | +972-526894497 | gutkovichj@gmail.com | |
| Miki Peker, M/D | Contact | cheifmiki2014@gmail.com |
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| Dual-energy X-ray absorptiometry at baseline | Diagnostic Test | Measuring T-score and Z-score of the femur and lumbar spine at baseline |
|
|
| cervical Vestibular evoked myogenic potentials at baseline | Diagnostic Test | 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. |
|
|
| Audiogram at baseline | Diagnostic Test | 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. |
|
|
| Measuring Orthostatic Blood Pressure at baseline | Diagnostic Test | 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 |
|
|
| cold pressor test at baseline | Diagnostic Test | 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. |
|
| vitamin D plasma levels one year after recruitment | Diagnostic Test | Measuring vitamin D plasma levels one year after recruitment |
|
| vitamin D plasma levels two years after recruitment | Diagnostic Test | Measuring vitamin D plasma levels two years after recruitment |
|
| Dual-energy X-ray absorptiometry one year after recruitment | Diagnostic Test | Measuring T-score and Z-score of the femur and lumbar spine one year after recruitment |
|
|
| Dual-energy X-ray absorptiometry two years after recruitment | Diagnostic Test | Measuring T-score and Z-score of the femur and lumbar spine two years after recruitment |
|
| cervical Vestibular evoked myogenic potentials one year after recruitment | Diagnostic Test | 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 |
|
|
| cervical Vestibular evoked myogenic potentials two years after recruitment | Diagnostic Test | 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 |
|
|
| Audiogram one year after recruitment | Diagnostic Test | 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 |
|
|
| Audiogram two years after recruitment | Diagnostic Test | 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 |
|
|
| Measuring Orthostatic Blood Pressure one year after recruitment | Diagnostic Test | 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 |
|
|
| Measuring Orthostatic Blood Pressure two years after recruitment | Diagnostic Test | 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. |
|
|
| cold pressor test one year after recruitment | Diagnostic Test | 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. |
|
| cold pressor test two years after recruitment | Diagnostic Test | 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. |
|
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 |
| ID | Term |
|---|---|
| D008575 | Meniere Disease |
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D014808 | Vitamin D Deficiency |
| D015837 | Vestibular Diseases |
| ID | Term |
|---|---|
| D018159 | Endolymphatic Hydrops |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D006320 | Hearing Tests |
| D015502 | Absorptiometry, Photon |
| D058585 | Vestibular Evoked Myogenic Potentials |
| D001299 | Audiometry |
| ID | Term |
|---|---|
| D003939 | Diagnostic Techniques, Otological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D019054 | Evoked Potentials, Motor |
| D005071 | Evoked Potentials |
| D000071080 | Cortical Excitability |
| D055724 | Electrophysiological Phenomena |
| D010829 | Physiological Phenomena |
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