Meniere's DiseasePhase 1/2NCT06001593
Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation
A Phase 1/2 study testing YPS-201b and betahistine in people with Meniere's Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Meniere's Disease
- What is being tested?
- YPS-201b and betahistine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Sep 2023to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Dong-min Kang contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Myung-Whan Suh
About this study
Official title: Pilot Study of Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation: Double-blind, Randomized, Sham-controlled, Investigator-initiated 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.
- Conditions
- Meniere's Disease
- Being tested
- YPS-201b, betahistine
- Keywords
- Electrical stimulation, Electroceutical, Meniere's disease
- Medical subject headings
- Meniere Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YPS-201bDevice
electrical stimulation device.
betahistineDrug
Relieve symptoms of balance disorders or dizziness
YPS-201bDevice
sham electrical stimulation device.
| Study group | Role | What they receive |
|---|---|---|
| electircal stimulation + betahistine | Experimental | Not described Receives: Device: YPS-201b; Drug: betahistine |
| sham electircal stimulation + betahistine | Sham comparator | Not described Receives: Drug: betahistine; Device: YPS-201b |
| betahistine | Other | control group Receives: Drug: betahistine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)
Verifying therapeutic effect of electrical stimulation
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0,1,4,8,12 weeks during electrical stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start18 Sep 2023
- Primary completionNov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniere's DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001593
- Sponsor's protocol ID
- 2304-098-1425
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation: Double-blind, Randomized, Sham-controlled, Investigator-initiated Trial
- ClinicalTrials.gov ID
- NCT06001593
- Acronym / sponsor ID
- 2304-098-1425
- Conditions
- Meniere's Disease
- Keywords
- Electrical stimulation, Electroceutical, Meniere's disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| electircal stimulation + betahistine | Experimental | Device: YPS-201b, Drug: betahistine |
| sham electircal stimulation + betahistine | Sham comparator | Drug: betahistine, Device: YPS-201b |
| betahistine | Other | Drug: betahistinecontrol group |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YPS-201belectrical stimulation device. | Device | electircal stimulation + betahistine |
| betahistineRelieve symptoms of balance disorders or dizziness | Drug | betahistine, electircal stimulation + betahistine, sham electircal stimulation + betahistine |
| YPS-201bsham electrical stimulation device. | Device | sham electircal stimulation + betahistine |
Primary outcome
Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)
Time frame: 0,2,4,8,12 weeks during electrical stimulation
Verifying therapeutic effect of electrical stimulation
Evaluate vestibular-ocular reflex with Video head impulse test(Efficacy)
Time frame: 0,4,8,12 weeks during electrical stimulation
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.
Valuation of hearing threshold with pure tone audiometry(Efficacy)
Time frame: 0,4,8,12 weeks during electrical stimulation
Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing.
electroencephalography(Efficacy)
Time frame: 0,1,4,8,12 weeks during electrical stimulation
Verifying therapeutic effect of electrical stimulation,evaluate the inhibitory response of the brain through EEG readings following repeated stimulation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Meniere's Disease
Active, not recruiting
CI Following VS Removal or Labyrinthectomy
Vestibular Schwannoma, Meniere Disease
Active, not recruitingPhase 3
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Meniere's Disease, Ménière's Disease
RecruitingObservational study
Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
Meniere's Disease, Enlarged Vestibular Aqueduct Syndrome
RecruitingPhase 4
Treatment of Meniere's Disease With Migraine Medications
Ménière
RecruitingPhase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
Autoimmune Inner Ear Disease, Meniere's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-min Kang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing YPS-201b and betahistine in people with Meniere's Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myung-Whan Suh (+821039490330, drmung@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy) (time frame: 0,2,4,8,12 weeks during electrical stimulation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.