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This study is a Double-blind, Randomized, Sham-controlled, Investigator-initiated trial. To explore the effectiveness of non-invasive inner ear electrical stimulation of the mastoid behind the ear in controlling auditory symptoms and dizziness in patients with Meniere's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| electircal stimulation + betahistine | Experimental |
| |
| sham electircal stimulation + betahistine | Sham Comparator |
| |
| betahistine | Other | control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YPS-201b | Device | electrical stimulation device. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy) | Verifying therapeutic effect of electrical stimulation | 0,2,4,8,12 weeks during electrical stimulation |
| Evaluate vestibular-ocular reflex with Video head impulse test(Efficacy) | Verifying therapeutic effect of electrical stimulation,evaluate the function of the vestibulocochlear reflex in the semicircular canal and measure the extent of improvement in Meniere's disease. | 0,4,8,12 weeks during electrical stimulation |
| Valuation of hearing threshold with pure tone audiometry(Efficacy) | Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing. | 0,4,8,12 weeks during electrical stimulation |
| electroencephalography(Efficacy) | Verifying therapeutic effect of electrical stimulation,evaluate the inhibitory response of the brain through EEG readings following repeated stimulation. | 0,1,4,8,12 weeks during electrical stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myung-Whan Suh | Contact | +821039490330 | drmung@naver.com | |
| Dong-min Kang | Contact | dongmin_4@naver.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D008575 | Meniere Disease |
| ID | Term |
|---|---|
| D018159 | Endolymphatic Hydrops |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D001621 | Betahistine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| betahistine |
| Drug |
Relieve symptoms of balance disorders or dizziness |
|
| YPS-201b | Device | sham electrical stimulation device. |
|