Menier's Disease - Bone Density Study
Not Applicable
Not yet recruiting
- Conditions
- OsteoporosisVitamin D DeficiencyOsteopeniaVestibular DisorderMeniere Disease
- Interventions
- Diagnostic Test: vitamin D plasma levels baselineDiagnostic Test: Dual-energy X-ray absorptiometry at baselineDiagnostic Test: cervical Vestibular evoked myogenic potentials at baselineDiagnostic Test: cold pressor test at baselineDiagnostic Test: Audiogram at baselineDiagnostic Test: Measuring Orthostatic Blood Pressure at baselineDiagnostic Test: vitamin D plasma levels one year after recruitmentDiagnostic Test: vitamin D plasma levels two years after recruitmentDiagnostic Test: Dual-energy X-ray absorptiometry one year after recruitmentDiagnostic Test: Dual-energy X-ray absorptiometry two years after recruitmentDiagnostic Test: cervical Vestibular evoked myogenic potentials one year after recruitmentDiagnostic Test: cervical Vestibular evoked myogenic potentials two years after recruitmentDiagnostic Test: Audiogram one year after recruitmentDiagnostic Test: Audiogram two years after recruitmentDiagnostic Test: Measuring Orthostatic Blood Pressure one year after recruitmentDiagnostic Test: Measuring Orthostatic Blood Pressure two years after recruitmentDiagnostic Test: cold pressor test one year after recruitmentDiagnostic Test: cold pressor test two years after recruitment
- Registration Number
- NCT05322538
- Lead Sponsor
- HaEmek Medical Center, Israel
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Definite Meniere's disease vitamin D plasma levels one year after recruitment Patients with Definite Meniere's disease Definite Meniere's disease vitamin D plasma levels baseline Patients with Definite Meniere's disease Controls vitamin D plasma levels baseline Healthy controls with no known vestibular disease Controls Dual-energy X-ray absorptiometry at baseline Healthy controls with no known vestibular disease Definite Meniere's disease cervical Vestibular evoked myogenic potentials at baseline Patients with Definite Meniere's disease Definite Meniere's disease Measuring Orthostatic Blood Pressure at baseline Patients with Definite Meniere's disease Definite Meniere's disease vitamin D plasma levels two years after recruitment Patients with Definite Meniere's disease Definite Meniere's disease Audiogram one year after recruitment Patients with Definite Meniere's disease Controls cold pressor test at baseline Healthy controls with no known vestibular disease Definite Meniere's disease cold pressor test at baseline Patients with Definite Meniere's disease Controls Measuring Orthostatic Blood Pressure at baseline Healthy controls with no known vestibular disease Definite Meniere's disease Dual-energy X-ray absorptiometry at baseline Patients with Definite Meniere's disease Definite Meniere's disease Dual-energy X-ray absorptiometry two years after recruitment Patients with Definite Meniere's disease Definite Meniere's disease Audiogram at baseline Patients with Definite Meniere's disease Definite Meniere's disease Measuring Orthostatic Blood Pressure two years after recruitment Patients with Definite Meniere's disease Definite Meniere's disease cervical Vestibular evoked myogenic potentials one year after recruitment Patients with Definite Meniere's disease Definite Meniere's disease cervical Vestibular evoked myogenic potentials two years after recruitment Patients with Definite Meniere's disease Definite Meniere's disease Measuring Orthostatic Blood Pressure one year after recruitment Patients with Definite Meniere's disease Definite Meniere's disease cold pressor test one year after recruitment Patients with Definite Meniere's disease Definite Meniere's disease cold pressor test two years after recruitment Patients with Definite Meniere's disease Definite Meniere's disease Dual-energy X-ray absorptiometry one year after recruitment Patients with Definite Meniere's disease Definite Meniere's disease Audiogram two years after recruitment Patients with Definite Meniere's disease
- Primary Outcome Measures
Name Time Method Z-score and T-score of femur and lumbur spine two years follow-up DEXA exam - bone density. higher score means better resuls. osteopenia is defined as \<-1 score , osteoporosis is defined as \<-2.5 score
Vitamin D plasma levels two years follow-up Vitamin D plasma levels
- Secondary Outcome Measures
Name Time Method Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam two years follow-up audiology exam
ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test two years follow-up cervical vestibular evoked myogenic potential exam
positive ortostatic hypotension Two years follow-up 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 two years follow-up a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function