[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464041":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":41,"centralContacts":127,"locations":41,"responsibleParty":136,"collaborators":41,"id":140,"slug":141,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":41,"eligibilityCriteria":145,"healthyVolunteers":146,"sex":147,"minAge":148,"maxAge":41,"enrollmentInfo":149,"targetDuration":41,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":41,"overallStatus":162,"whyStopped":41,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":41},{"fullName":5,"class":6},"HaEmek Medical Center, Israel","OTHER",[8,16],{"label":9,"type":6,"description":10,"interventionNames":11},"Controls","Healthy controls with no known vestibular disease",[12,13,14,15],"Diagnostic Test: vitamin D plasma levels baseline","Diagnostic Test: Dual-energy X-ray absorptiometry at baseline","Diagnostic Test: Measuring Orthostatic Blood Pressure at baseline","Diagnostic Test: cold pressor test at baseline",{"label":17,"type":18,"description":19,"interventionNames":20},"Definite Meniere's disease","EXPERIMENTAL","Patients with Definite Meniere's disease",[12,13,21,22,14,15,23,24,25,26,27,28,29,30,31,32,33,34],"Diagnostic Test: cervical Vestibular evoked myogenic potentials at baseline","Diagnostic Test: Audiogram 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",[36,42,48,54,60,66,70,74,78,83,87,92,97,102,107,113,119,123],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DIAGNOSTIC_TEST","vitamin D plasma levels baseline","Measuring vitamin D plasma levels at baseline",[9,17],null,{"type":37,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Dual-energy X-ray absorptiometry at baseline","Measuring T-score and Z-score of the femur and lumbar spine at baseline",[9,17],[47],"DEXA",{"type":37,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"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.",[17],[53],"cVEMP",{"type":37,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"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.",[17],[59],"Hearing test",{"type":37,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"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",[9,17],[65],"Orthostatic Hypotension",{"type":37,"name":67,"description":68,"armGroupLabels":69,"otherNames":41},"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.",[9,17],{"type":37,"name":71,"description":72,"armGroupLabels":73,"otherNames":41},"vitamin D plasma levels one year after recruitment","Measuring vitamin D plasma levels one year after recruitment",[17],{"type":37,"name":75,"description":76,"armGroupLabels":77,"otherNames":41},"vitamin D plasma levels two years after recruitment","Measuring vitamin D plasma levels two years after recruitment",[17],{"type":37,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"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",[17],[47],{"type":37,"name":84,"description":85,"armGroupLabels":86,"otherNames":41},"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",[17],{"type":37,"name":88,"description":89,"armGroupLabels":90,"otherNames":91},"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",[17],[53],{"type":37,"name":93,"description":94,"armGroupLabels":95,"otherNames":96},"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",[17],[53],{"type":37,"name":98,"description":99,"armGroupLabels":100,"otherNames":101},"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",[17],[59],{"type":37,"name":103,"description":104,"armGroupLabels":105,"otherNames":106},"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",[17],[59],{"type":37,"name":108,"description":109,"armGroupLabels":110,"otherNames":111},"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",[17],[112],"Ortostatic hypostension",{"type":37,"name":114,"description":115,"armGroupLabels":116,"otherNames":117},"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.",[17],[118],"Ostostatic hypotension",{"type":37,"name":120,"description":121,"armGroupLabels":122,"otherNames":41},"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.",[17],{"type":37,"name":124,"description":125,"armGroupLabels":126,"otherNames":41},"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.",[17],[128,133],{"name":129,"role":130,"phone":131,"phoneExt":41,"email":132},"Yoni Evgeni Gutkovich, M.D\\Ph.D","CONTACT","+972-526894497","gutkovichj@gmail.com",{"name":134,"role":130,"phone":41,"phoneExt":41,"email":135},"Miki Peker, M\u002FD","cheifmiki2014@gmail.com",{"type":137,"investigatorFullName":138,"investigatorTitle":139,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"PRINCIPAL_INVESTIGATOR","Paker Miki","Attending physician, Otolaryngology head and neck surgery department","100464041","meniers-disease---bone-density-study-100464041",false,"NCT05322538","Menier's Disease - Bone Density Study","Inclusion Criteria:\n\n* Definite Meniere's disease\n\nExclusion Criteria:\n\n* hyperthyroidism\n* hyperparathyroidism\n* acromegaly\n* hypogonadism\n* diabetes melitus\n* chronic renal failure\n* alcoholism\n* cushing syndrome\n* rheumatoid arthritis\n* systemic lupus erythematosus\n* ankylosing spondylitis\n* inflammatory bowel disease\n* obstructive lung disease\n* sarcoidosis\n* amyloidosis\n* celiac disease.\n* chronic treatment with bisphosphonates\n* chronic treatment with glucocorticoids\n* chronic treatment with androgen deprivation therapy\n* 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",true,"ALL","18 Years",{"count":150,"type":151},60,"ESTIMATED","INTERVENTIONAL",[154],"NA","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.",[157,158,159,160,161],"Meniere Disease","Osteoporosis","Osteopenia","Vitamin D Deficiency","Vestibular Disorder","NOT_YET_RECRUITING","2022-08-02",{"date":165,"type":166},"2022-08-03","ACTUAL",{"date":168,"type":151},"2022-10-01",{"date":170,"type":151},"2028-12-31",{"name":5,"class":6}]