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RecruitingNCT06001593

Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation

Pilot Study of Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation: Double-blind, Randomized, Sham-controlled, Investigator-initiated Trial

Status
Recruiting
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
Seoul National University Hospital · Academic / Other
Sex
All
Age
19 Years – 80 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEYPS-201belectrical stimulation device.
DRUGbetahistineRelieve symptoms of balance disorders or dizziness
DEVICEYPS-201bsham electrical stimulation device.

Timeline

Start date
2023-09-18
Primary completion
2025-11-01
Completion
2025-12-31
First posted
2023-08-21
Last updated
2024-12-05

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT06001593. Inclusion in this directory is not an endorsement.

Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation (NCT06001593) · Clinical Trials Directory