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

Last updated: December 2, 2024
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

1/2

Condition

Vomiting

Hearing Loss

Deafness

Treatment

YPS-201b

betahistine

Clinical Study ID

NCT06001593
2304-098-1425
  • Ages 19-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with dizziness (Meniere's) only, who understand the nature of the study andare willing to participate voluntarily.

  • The frequency of the hearing loss is between 250 kHz and 1 kHz.

  • Patients with bilateral 500, 1000, and 2000 Hz hearing threshold averages within 65dB HL

  • Patients who have received conventional pharmacotherapy for other dizzinessconditions with a washout period of 2 months.

  • To be eligible for subjects in the active phase of the disease, there must be atleast 1 vertigo attack in the 6 months before study entry.

  • If tests for renal function, electrolytes, etc. are performed and no problems arefound

Exclusion

Exclusion Criteria:

  • Patients with an otologic condition other than Meniere'ss (dizziness) (otitis media,profound hearing loss, hyperacusis, etc.).

  • Patients' conditions that may affect EEG measurements, such as a stroke, brainhemorrhage, or brain tumor.

  • Patients with kidney disease

  • Patients Have or have had a serious medical condition, such as cancer (includingleukemia, blood cancers, epilepsy, and neuropsychiatric conditions).

  • Patients with an artificial implant in the body (cochlear implant, hip joint,pacemaker, etc.)

  • Women of childbearing potential, pregnant women, or nursing mothers

  • Patients who can have Injuries or dermatologic abnormalities at the site ofapplication of the equipment.

  • Patients with coronary artery disease, uncontrolled high blood pressure, or otherserious medical conditions (including kidney disease).

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: YPS-201b
Phase: 1/2
Study Start date:
September 18, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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