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

NCT ID: NCT06001593

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Meniere's Disease

Keywords

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Electrical stimulation Electroceutical Meniere's disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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electircal stimulation + betahistine

Group Type EXPERIMENTAL

YPS-201b

Intervention Type DEVICE

electrical stimulation device.

betahistine

Intervention Type DRUG

Relieve symptoms of balance disorders or dizziness

sham electircal stimulation + betahistine

Group Type SHAM_COMPARATOR

betahistine

Intervention Type DRUG

Relieve symptoms of balance disorders or dizziness

YPS-201b

Intervention Type DEVICE

sham electrical stimulation device.

betahistine

control group

Group Type OTHER

betahistine

Intervention Type DRUG

Relieve symptoms of balance disorders or dizziness

Interventions

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YPS-201b

electrical stimulation device.

Intervention Type DEVICE

betahistine

Relieve symptoms of balance disorders or dizziness

Intervention Type DRUG

YPS-201b

sham electrical stimulation device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

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, 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).
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Myung-Whan Suh

Role: CONTACT

Phone: +821039490330

Email: [email protected]

Dong-min Kang

Role: CONTACT

Email: [email protected]

Facility Contacts

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Myung-Whan Suh

Role: primary

Other Identifiers

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2304-098-1425

Identifier Type: -

Identifier Source: org_study_id