Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation
NCT06001593 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2024-12-05
Summary
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.
Conditions
- Meniere's Disease
Interventions
- DEVICE
-
YPS-201b
electrical stimulation device.
- DRUG
-
betahistine
Relieve symptoms of balance disorders or dizziness
- DEVICE
-
YPS-201b
sham electrical stimulation device.
Sponsors & Collaborators
-
Seoul National University Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-18
- Primary Completion
- 2025-11-30
- Completion
- 2025-12-31
Countries
- South Korea
Study Locations
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