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NCT Number: NCT05322538

Menier's Disease - Bone Density Study

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.

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Key information

Conditions

Meniere Disease Avitaminosis Bone Diseases Bone Diseases, Metabolic Deficiency Diseases Ear Diseases Endolymphatic Hydrops Labyrinth Diseases Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Osteopenia Osteoporosis Otorhinolaryngologic Diseases Vestibular Diseases Vestibular Disorder Vitamin D Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vitamin D plasma levels baseline

Diagnostic Test

Measuring vitamin D plasma levels at baseline

Dual-energy X-ray absorptiometry at baseline

Diagnostic Test

Measuring T-score and Z-score of the femur and lumbar spine at baseline

Other names: DEXA

cervical Vestibular evoked myogenic potentials at baseline

Diagnostic Test

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.

Other names: cVEMP

Audiogram at baseline

Diagnostic Test

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.

Other names: Hearing test

Measuring Orthostatic Blood Pressure at baseline

Diagnostic Test

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

Other names: Orthostatic Hypotension

cold pressor test at baseline

Diagnostic 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.

vitamin D plasma levels one year after recruitment

Diagnostic Test

Measuring vitamin D plasma levels one year after recruitment

vitamin D plasma levels two years after recruitment

Diagnostic Test

Measuring vitamin D plasma levels two years after recruitment

Dual-energy X-ray absorptiometry one year after recruitment

Diagnostic Test

Measuring T-score and Z-score of the femur and lumbar spine one year after recruitment

Other names: DEXA

Dual-energy X-ray absorptiometry two years after recruitment

Diagnostic Test

Measuring T-score and Z-score of the femur and lumbar spine two years after recruitment

cervical Vestibular evoked myogenic potentials one year after recruitment

Diagnostic Test

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

Other names: cVEMP

cervical Vestibular evoked myogenic potentials two years after recruitment

Diagnostic Test

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

Other names: cVEMP

Audiogram one year after recruitment

Diagnostic Test

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

Other names: Hearing test

Audiogram two years after recruitment

Diagnostic Test

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

Other names: Hearing test

Measuring Orthostatic Blood Pressure one year after recruitment

Diagnostic Test

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

Other names: Ortostatic hypostension

Measuring Orthostatic Blood Pressure two years after recruitment

Diagnostic Test

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.

Other names: Ostostatic hypotension

cold pressor test one year after recruitment

Diagnostic 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. The test will be performed one year after recruitment.

cold pressor test two years after recruitment

Diagnostic 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. The test will be performed two years after recruitment.

Primary outcomes

  1. Vitamin D plasma levels

    Time frame: baseline

    Vitamin D plasma levels

  2. Vitamin D plasma levels

    Time frame: one year follow up

    Vitamin D plasma levels

  3. Vitamin D plasma levels

    Time frame: two years follow-up

    Vitamin D plasma levels

  4. Z-score and T-score of femur and lumbur spine

    Time frame: baseline

    DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score

  5. Z-score and T-score of femur and lumbur spine

    Time frame: one year follow up

    DEXA exam - bone density. higher score means better resuls. osteopenia is defined as <-1 score , osteoporosis is defined as <-2.5 score

  6. Z-score and T-score of femur and lumbur spine

    Time frame: 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

Secondary outcomes

  1. positive ortostatic hypotension

    Time frame: baseline

    drop of 20mmHg systolic blood pressure or drop of 10mmHG diastolic blood pressure after 3 minutes of standing up. all other results - negetive

  2. positive ortostatic hypotension

    Time frame: one year 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

  3. positive ortostatic hypotension

    Time frame: 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

  4. cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete

    Time frame: baseline

    a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function

  5. cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete

    Time frame: one year follow up

    a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function

  6. cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete

    Time frame: two years follow-up

    a rise of less then 15mmHg after the test is considered inadequete function, more then 15hhHg - normal function

  7. ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test

    Time frame: baseline

    cervical vestibular evoked myogenic potential exam

  8. ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test

    Time frame: one year follow up

    cervical vestibular evoked myogenic potential exam

  9. ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test

    Time frame: two years follow-up

    cervical vestibular evoked myogenic potential exam

  10. Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam

    Time frame: baseline

    audiology exam

  11. Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam

    Time frame: one year follow up

    audiology exam

  12. Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam

    Time frame: two years follow-up

    audiology exam

Study contacts

Contact information is provided by the study sponsor or research team.

Miki Peker, M/D

CONTACT

[email protected]

Yoni Evgeni Gutkovich, M.D\Ph.D

CONTACT

[email protected]

+972-526894497

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Apr 12, 2022
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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