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Menier's Disease - Bone Density Study

Primary Purpose

Meniere Disease, Osteoporosis, Osteopenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
vitamin D plasma levels baseline
Dual-energy X-ray absorptiometry at baseline
cervical Vestibular evoked myogenic potentials at baseline
Audiogram at baseline
Measuring Orthostatic Blood Pressure at baseline
cold pressor test at baseline
vitamin D plasma levels one year after recruitment
vitamin D plasma levels two years after recruitment
Dual-energy X-ray absorptiometry one year after recruitment
Dual-energy X-ray absorptiometry two years after recruitment
cervical Vestibular evoked myogenic potentials one year after recruitment
cervical Vestibular evoked myogenic potentials two years after recruitment
Audiogram one year after recruitment
Audiogram two years after recruitment
Measuring Orthostatic Blood Pressure one year after recruitment
Measuring Orthostatic Blood Pressure two years after recruitment
cold pressor test one year after recruitment
cold pressor test two years after recruitment
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Meniere Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Controls

    Definite Meniere's disease

    Arm Description

    Healthy controls with no known vestibular disease

    Patients with Definite Meniere's disease

    Outcomes

    Primary Outcome Measures

    Vitamin D plasma levels
    Vitamin D plasma levels
    Vitamin D plasma levels
    Vitamin D plasma levels
    Vitamin D plasma levels
    Vitamin D plasma levels
    Z-score and T-score of femur and lumbur spine
    DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score
    Z-score and T-score of femur and lumbur spine
    DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score
    Z-score and T-score of femur and lumbur spine
    DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score

    Secondary Outcome Measures

    positive ortostatic hypotension
    drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive
    positive ortostatic hypotension
    drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive
    positive ortostatic hypotension
    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
    a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function
    cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
    a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function
    cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
    a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function
    ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
    cervical vestibular evoked myogenic potential exam
    ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
    cervical vestibular evoked myogenic potential exam
    ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
    cervical vestibular evoked myogenic potential exam
    Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
    audiology exam
    Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
    audiology exam
    Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
    audiology exam

    Full Information

    First Posted
    March 16, 2022
    Last Updated
    August 2, 2022
    Sponsor
    HaEmek Medical Center, Israel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05322538
    Brief Title
    Menier's Disease - Bone Density Study
    Official Title
    Menier's Disease - Bone Density Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    June 30, 2028 (Anticipated)
    Study Completion Date
    December 31, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    HaEmek Medical Center, Israel

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Meniere Disease, Osteoporosis, Osteopenia, Vitamin D Deficiency, Vestibular Disorder

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Controls
    Arm Type
    Other
    Arm Description
    Healthy controls with no known vestibular disease
    Arm Title
    Definite Meniere's disease
    Arm Type
    Experimental
    Arm Description
    Patients with Definite Meniere's disease
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    vitamin D plasma levels baseline
    Intervention Description
    Measuring vitamin D plasma levels at baseline
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Dual-energy X-ray absorptiometry at baseline
    Other Intervention Name(s)
    DEXA
    Intervention Description
    Measuring T-score and Z-score of the femur and lumbar spine at baseline
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    cervical Vestibular evoked myogenic potentials at baseline
    Other Intervention Name(s)
    cVEMP
    Intervention Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Audiogram at baseline
    Other Intervention Name(s)
    Hearing test
    Intervention Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Measuring Orthostatic Blood Pressure at baseline
    Other Intervention Name(s)
    Orthostatic Hypotension
    Intervention Description
    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
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    cold pressor test at baseline
    Intervention Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    vitamin D plasma levels one year after recruitment
    Intervention Description
    Measuring vitamin D plasma levels one year after recruitment
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    vitamin D plasma levels two years after recruitment
    Intervention Description
    Measuring vitamin D plasma levels two years after recruitment
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Dual-energy X-ray absorptiometry one year after recruitment
    Other Intervention Name(s)
    DEXA
    Intervention Description
    Measuring T-score and Z-score of the femur and lumbar spine one year after recruitment
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Dual-energy X-ray absorptiometry two years after recruitment
    Intervention Description
    Measuring T-score and Z-score of the femur and lumbar spine two years after recruitment
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    cervical Vestibular evoked myogenic potentials one year after recruitment
    Other Intervention Name(s)
    cVEMP
    Intervention Description
    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
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    cervical Vestibular evoked myogenic potentials two years after recruitment
    Other Intervention Name(s)
    cVEMP
    Intervention Description
    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
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Audiogram one year after recruitment
    Other Intervention Name(s)
    Hearing test
    Intervention Description
    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
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Audiogram two years after recruitment
    Other Intervention Name(s)
    Hearing test
    Intervention Description
    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
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Measuring Orthostatic Blood Pressure one year after recruitment
    Other Intervention Name(s)
    Ortostatic hypostension
    Intervention Description
    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
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Measuring Orthostatic Blood Pressure two years after recruitment
    Other Intervention Name(s)
    Ostostatic hypotension
    Intervention Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    cold pressor test one year after recruitment
    Intervention Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    cold pressor test two years after recruitment
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Vitamin D plasma levels
    Description
    Vitamin D plasma levels
    Time Frame
    baseline
    Title
    Vitamin D plasma levels
    Description
    Vitamin D plasma levels
    Time Frame
    one year follow up
    Title
    Vitamin D plasma levels
    Description
    Vitamin D plasma levels
    Time Frame
    two years follow-up
    Title
    Z-score and T-score of femur and lumbur spine
    Description
    DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score
    Time Frame
    baseline
    Title
    Z-score and T-score of femur and lumbur spine
    Description
    DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score
    Time Frame
    one year follow up
    Title
    Z-score and T-score of femur and lumbur spine
    Description
    DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score
    Time Frame
    two years follow-up
    Secondary Outcome Measure Information:
    Title
    positive ortostatic hypotension
    Description
    drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive
    Time Frame
    baseline
    Title
    positive ortostatic hypotension
    Description
    drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive
    Time Frame
    one year follow up
    Title
    positive ortostatic hypotension
    Description
    drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive
    Time Frame
    Two years follow-up
    Title
    cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
    Description
    a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function
    Time Frame
    baseline
    Title
    cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
    Description
    a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function
    Time Frame
    one year follow up
    Title
    cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
    Description
    a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function
    Time Frame
    two years follow-up
    Title
    ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
    Description
    cervical vestibular evoked myogenic potential exam
    Time Frame
    baseline
    Title
    ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
    Description
    cervical vestibular evoked myogenic potential exam
    Time Frame
    one year follow up
    Title
    ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test
    Description
    cervical vestibular evoked myogenic potential exam
    Time Frame
    two years follow-up
    Title
    Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
    Description
    audiology exam
    Time Frame
    baseline
    Title
    Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
    Description
    audiology exam
    Time Frame
    one year follow up
    Title
    Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam
    Description
    audiology exam
    Time Frame
    two years follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yoni Evgeni Gutkovich, M.D\Ph.D
    Phone
    +972-526894497
    Email
    gutkovichj@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Miki Peker, M/D
    Email
    cheifmiki2014@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Menier's Disease - Bone Density Study

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