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
About this trial
This is an interventional diagnostic trial for Meniere Disease
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
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
NCT ID
NCT05322538
First Posted
March 16, 2022
Last Updated
August 2, 2022
Sponsor
HaEmek Medical Center, Israel
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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