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Menier's Disease - Bone Density Study
Sponsor: HaEmek Medical Center, Israel
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2022-10-01
Completion Date
2028-12-31
Last Updated
2022-08-03
Healthy Volunteers
Yes
Interventions
vitamin D plasma levels baseline
Measuring vitamin D plasma levels at baseline
Dual-energy X-ray absorptiometry at baseline
Measuring T-score and Z-score of the femur and lumbar spine at baseline
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.
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.
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
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.
vitamin D plasma levels one year after recruitment
Measuring vitamin D plasma levels one year after recruitment
vitamin D plasma levels two years after recruitment
Measuring vitamin D plasma levels two years after recruitment
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
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
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
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
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
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
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
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.
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.
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.