Actively Recruiting

Phase 1
Phase 2
Age: 19Years - 80Years
All Genders
NCT06001593

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

Led by Seoul National University Hospital · Updated on 2024-12-05

120

Participants Needed

1

Research Sites

119 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 19Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with dizziness due to Meniere's disease who understand the study and agree to participate voluntarily
  • Hearing loss frequencies between 250 kHz and 1 kHz
  • Bilateral hearing threshold averages of 65 dB HL or less at 500, 1000, and 2000 Hz
  • Patients who have stopped other dizziness treatments for at least 2 months
  • At least one vertigo attack in the 6 months before joining the study
  • Normal renal function and electrolyte test results if performed
Not Eligible

You will not qualify if you...

  • Otologic conditions other than Meniere's disease such as otitis media, profound hearing loss, or hyperacusis
  • Conditions affecting EEG measurements like stroke, brain hemorrhage, or brain tumor
  • Kidney disease
  • Serious medical conditions including cancer, epilepsy, or neuropsychiatric disorders
  • Presence of artificial implants like cochlear implants, pacemakers, or hip joints
  • Women who are pregnant, nursing, or of childbearing potential
  • Skin injuries or dermatologic problems at the device application site
  • Coronary artery disease, uncontrolled high blood pressure, or other serious medical issues including kidney disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Seoul National University Hospital

Seoul, South Korea

Actively Recruiting

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Research Team

M

Myung-Whan Suh

CONTACT

D

Dong-min Kang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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