NCT05322538

Menier's Disease - Bone Density Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Meniere Disease
• Osteoporosis
• Osteopenia
• Vitamin D Deficiency
• Vestibular Disorder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	vitamin D plasma levels baseline	Measuring vitamin D plasma levels at baseline
DIAGNOSTIC_TEST	Dual-energy X-ray absorptiometry at baseline	Measuring T-score and Z-score of the femur and lumbar spine at baseline
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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
DIAGNOSTIC_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.
DIAGNOSTIC_TEST	vitamin D plasma levels one year after recruitment	Measuring vitamin D plasma levels one year after recruitment
DIAGNOSTIC_TEST	vitamin D plasma levels two years after recruitment	Measuring vitamin D plasma levels two years after recruitment
DIAGNOSTIC_TEST	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
DIAGNOSTIC_TEST	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
DIAGNOSTIC_TEST	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
DIAGNOSTIC_TEST	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
DIAGNOSTIC_TEST	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
DIAGNOSTIC_TEST	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
DIAGNOSTIC_TEST	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
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2028-06-30
• Completion: 2028-12-31
• First posted: 2022-04-12
• Last updated: 2022-08-03