Meniere's Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with unilateral Meniere's disease (2015 barany) with hearing loss, recurrent vertigo, and ineffective drug treatment for at least 6 months (vertigo episodes >=1 time/month). The contralateral ear should have normal, age-appropriate hearing. 2. Pure tone audiometry shows that the average threshold of the three frequencies of 500, 1k, and 2k Hz is >= 60dB HL, and (or) the speech recognition rate is <=50%.
Exclusion criteria
Exclusion criteria: 1. Cerebellopontine angle tumor or other intracranial space-occupying lesions; 2. Age: The patient was older than 70 years old at the beginning of the trial; 3. Severe disability (such as neurological, orthopedic, cardiovascular) or serious concurrent diseases, which may affect treatment or follow-up; 4. Concurrent middle ear disease (such as active middle ear disease) that may interfere with treatment; 5. Patients who cannot bear the risk of surgery; 6. Known history of adverse/allergic reactions to anesthetics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vergito attack controlling rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| hearing loss rate;speech recognition rate;one-sided weakening value of hot and cold test;caloric test DP value;vestibular evoked myogenic potential asymmetry;HIT gain;recovery time from imbalance;sensory organization test score;DHI scale score;vertigo symptom scale-shot form (VSS-sf);tinnitus disability scale score;aural fullness subjective improvement scale(AFSIS) score;function level scale (FLS);Me'nie`re’s disease outcome questionnaire (MDOQ);facial paralysis;cerebrospinal fluid leakage;infection;imbalance; | — |
Countries
China
Contacts
Shandong Second Provincial General Hospital (Shandong Provincial ENT Hospital)