Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2022-10-01
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Controls
Healthy controls with no known vestibular disease
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
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.
Definite Meniere's disease
Patients with Definite Meniere's disease
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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Paker Miki
Attending physician, Otolaryngology head and neck surgery department
Central Contacts
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Other Identifiers
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EMC-22-0031
Identifier Type: -
Identifier Source: org_study_id
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