NCT06001593

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

September 18, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 5, 2024

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

July 24, 2023

Last Update Submit

December 2, 2024

Conditions

Meniere's Disease

Keywords

Electrical stimulationElectroceuticalMeniere's disease

Outcome Measures

Primary Outcomes (4)

  • Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)

    Verifying therapeutic effect of electrical stimulation

    0,2,4,8,12 weeks during electrical stimulation

  • Evaluate vestibular-ocular reflex with Video head impulse test(Efficacy)

    Verifying therapeutic effect of electrical stimulation,evaluate the function of the vestibulocochlear reflex in the semicircular canal and measure the extent of improvement in Meniere's disease.

    0,4,8,12 weeks during electrical stimulation

  • Valuation of hearing threshold with pure tone audiometry(Efficacy)

    Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing.

    0,4,8,12 weeks during electrical stimulation

  • electroencephalography(Efficacy)

    Verifying therapeutic effect of electrical stimulation,evaluate the inhibitory response of the brain through EEG readings following repeated stimulation.

    0,1,4,8,12 weeks during electrical stimulation

Study Arms (3)

electircal stimulation + betahistine

EXPERIMENTAL
Device: YPS-201bDrug: betahistine

sham electircal stimulation + betahistine

SHAM COMPARATOR
Drug: betahistineDevice: YPS-201b

betahistine

OTHER

control group

Drug: betahistine

Interventions

YPS-201bDEVICE

electrical stimulation device.

electircal stimulation + betahistine
betahistineDRUG

Relieve symptoms of balance disorders or dizziness

betahistineelectircal stimulation + betahistinesham electircal stimulation + betahistine

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • To be eligible for subjects in the active phase of the disease, there must be at least 1 vertigo attack in the 6 months before study entry.
  • If tests for renal function, electrolytes, etc. are performed and no problems are found

You may not qualify if:

  • 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).
  • 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 of application of the equipment.
  • Patients with coronary artery disease, uncontrolled high blood pressure, or other serious medical conditions (including kidney disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Meniere Disease

Interventions

Betahistine

Condition Hierarchy (Ancestors)

Endolymphatic HydropsLabyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Myung-Whan Suh

CONTACT

+821039490330drmung@naver.com

Dong-min Kang

CONTACT

dongmin_4@naver.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2023

First Posted

August 21, 2023

Study Start

September 18, 2023

Primary Completion

November 1, 2025

Study Completion

December 31, 2025

Last Updated

December 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)