Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT06001593
Eligibility Criteria:
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT06001593
Study Brief:
Protocol Section:
NCT06001593