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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19-80
SponsorSeoul National University Hospital

About this trial

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

Qualifiers

Patients with dizziness (Meniere's) only, who understand the nature of the study and are 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 65 dB HL

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

Disqualifiers

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, brain hemorrhage, or brain tumor.

Patients with kidney disease

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

Trial design

Treatments tested in this trial

  • YPS-201b
  • betahistine
  • YPS-201b

Treatment groups

120 Participants
are divided into 3 treatment groups