Health TrialsbyHealthPanel

Menier's Disease - Bone Density Study

ConditionsMeniere DiseaseOsteoporosisOsteopeniaVitamin D DeficiencyVestibular Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaEmek Medical Center, Israel

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Definite Meniere's disease

Disqualifiers

hyperthyroidism

hyperparathyroidism

acromegaly

hypogonadism

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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.

  • 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.

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ControlsOther 4 interventions
Group B: Definite Meniere's diseaseExperimental treatment 18 interventions

Trial outcomes

Primary outcomes

1

Vitamin D plasma levels

Vitamin D plasma levels

Time frame
baseline
2

Vitamin D plasma levels

Vitamin D plasma levels

Time frame
one year follow up
3

Vitamin D plasma levels

Vitamin D plasma levels

Time frame
two years follow-up
4

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

Time frame
baseline

Secondary outcomes

1

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

Time frame
baseline
2

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

Time frame
one year follow up
3

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

Time frame
Two years follow-up
4

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

Time frame
baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HaEmek Medical Center, Israel

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: