Menier's Disease - Bone Density Study
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2022
CompletedFirst Posted
Study publicly available on registry
April 12, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
August 3, 2022
August 1, 2022
5.8 years
March 16, 2022
August 2, 2022
Conditions
Outcome Measures
Primary Outcomes (6)
Vitamin D plasma levels
Vitamin D plasma levels
baseline
Vitamin D plasma levels
Vitamin D plasma levels
one year follow up
Vitamin D plasma levels
Vitamin D plasma levels
two years follow-up
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
baseline
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
one year follow up
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
two years follow-up
Secondary Outcomes (12)
positive ortostatic hypotension
baseline
positive ortostatic hypotension
one year follow up
positive ortostatic hypotension
Two years follow-up
cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
baseline
cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete
one year follow up
- +7 more secondary outcomes
Study Arms (2)
Controls
OTHERHealthy controls with no known vestibular disease
Definite Meniere's disease
EXPERIMENTALPatients with Definite Meniere's disease
Interventions
Measuring vitamin D plasma levels at baseline
Measuring T-score and Z-score of the femur and lumbar spine 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.
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.
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 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.
Measuring vitamin D plasma levels one year after recruitment
Measuring vitamin D plasma levels two years after recruitment
Measuring T-score and Z-score of the femur and lumbar spine one year after recruitment
Measuring T-score and Z-score of the femur and lumbar spine 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 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 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 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 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 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 two 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.
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.
Eligibility Criteria
You may qualify if:
- Definite Meniere's disease
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician, Otolaryngology head and neck surgery department
Study Record Dates
First Submitted
March 16, 2022
First Posted
April 12, 2022
Study Start
October 1, 2022
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
August 3, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share