Menier's Disease - Bone Density Study

Обзор

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.

Вмешательства

• Диагностический тест vitamin D plasma levels baseline
  Measuring vitamin D plasma levels at baseline
• Диагностический тест Dual-energy X-ray absorptiometry at baseline
  Measuring T-score and Z-score of the femur and lumbar spine at baseline
• Диагностический тест 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.
• Диагностический тест 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.
• Диагностический тест 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
• Диагностический тест 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.
• Диагностический тест vitamin D plasma levels one year after recruitment
  Measuring vitamin D plasma levels one year after recruitment
• Диагностический тест vitamin D plasma levels two years after recruitment
  Measuring vitamin D plasma levels two years after recruitment
• Диагностический тест 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
• Диагностический тест 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

Первичные конечные точки

• Vitamin D plasma levels [Срок оценки: baseline]
• Vitamin D plasma levels [Срок оценки: one year follow up]
• Vitamin D plasma levels [Срок оценки: two years follow-up]
• Z-score and T-score of femur and lumbur spine [Срок оценки: baseline]
• Z-score and T-score of femur and lumbur spine [Срок оценки: one year follow up]
• Z-score and T-score of femur and lumbur spine [Срок оценки: two years follow-up]

Вторичные конечные точки (12)

• positive ortostatic hypotension [Срок оценки: baseline]
• positive ortostatic hypotension [Срок оценки: one year follow up]
• positive ortostatic hypotension [Срок оценки: Two years follow-up]
• cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete [Срок оценки: baseline]
• cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete [Срок оценки: one year follow up]
• cold pressure - autonomous sympatetic nervous system function - normal vs, inadequete [Срок оценки: two years follow-up]
• ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test [Срок оценки: baseline]
• ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test [Срок оценки: one year follow up]
• ampitude, latency and peak to peak amplitude of the P13 and N23 waves in the cVEMP test [Срок оценки: two years follow-up]
• Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam [Срок оценки: baseline]
• Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam [Срок оценки: one year follow up]
• Hearing level (dB), SRT in dB , descrimination in (%) in the audiology exam [Срок оценки: two years follow-up]

Критерии участия

Критерии включения

• Definite Meniere's disease

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05322538 · EMC-22-0031

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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