Meniere Disease, Osteopenia, Osteoporosis, Vestibular Disorder, Vitamin D Deficiency
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTvitamin D plasma levels baseline
Measuring vitamin D plasma levels at baseline
DIAGNOSTIC_TESTDual-energy X-ray absorptiometry at baseline
Measuring T-score and Z-score of the femur and lumbar spine at baseline
DIAGNOSTIC_TESTcervical 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_TESTAudiogram 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_TESTMeasuring 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_TESTcold 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_TESTvitamin D plasma levels one year after recruitment
Measuring vitamin D plasma levels one year after recruitment
DIAGNOSTIC_TESTvitamin D plasma levels two years after recruitment
Measuring vitamin D plasma levels two years after recruitment
DIAGNOSTIC_TESTDual-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_TESTDual-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_TESTcervical 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_TESTcervical 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_TESTAudiogram 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_TESTAudiogram 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_TESTMeasuring 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_TESTMeasuring 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_TESTcold 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_TESTcold 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
HaEmek Medical Center, Israel
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D plasma levels | baseline | Vitamin D plasma levels |
| Z-score and T-score of femur and lumbur spine | baseline | DEXA exam - bone density. higher score means better resuls. osteopenia is defined as \<-1 score , osteoporosis is defined as \<-2.5 score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| positive ortostatic hypotension | baseline | drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive |
| cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete | baseline | a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function |
| ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test | baseline | cervical vestibular evoked myogenic potential exam |
| Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam | baseline | audiology exam |
Contacts
Primary ContactYoni Evgeni Gutkovich, M.D\Ph.D
Backup ContactMiki Peker, M/D
Outcome results
None listed