profound or total sudden sensorineural hearing loss
Conditions
Interventions
Group 2:intracochlear dexamethasone injection:Dexamethasone administered via round window membrane injection at a dose equivalent to 45µL of triamcinolone acetonide (40mg/mL)
Group 3: intratympanic dexamethasone injection tympanic membrane.:Inject dexamethasone 5 mg/ml into the tympanic cavity, once every other day, for a total of 4 injections
Group 1:intracochlear triamcinolone acetonide injection:Inject 45 µl of 40 mg/ml triamcinolone acetonide through the round window membrane.
Sponsors
Eye & ENT hospital of Fudan University
Eligibility
Sex/Gender
All
Age
12 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the clinical study; 2. Fully understand and be informed about this study and sign the informed consent form (ICF); 3. Willing to follow and capable of completing all trial procedures; 4. Age 12-75 years; 5. Pure tone test, CT, and MRI diagnosis of unilateral sudden deafness; 6. Sudden deafness symptoms occurring =7 days ago and, after conventional treatment, average thresholds at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz =80 dBHL.
Exclusion criteria
Exclusion criteria: 1. CT diagnosis of 'round window niche abnormality'; 2. Bilateral sudden deafness; 3. Hearing loss with known causes excluded (Meniere's disease, post-cochlear lesions, history of ear surgery, perilymph fistula, barotrauma, etc.); 4. Use of ototoxic treatment within 6 months (radiotherapy, chemotherapy, loop diuretics, high-dose aspirin); 5. History of sudden deafness within 2 years; history of ischemic diseases (cerebral infarction, myocardial infarction, peripheral arterial occlusive disease); 6. Neuropsychiatric diseases (epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis); 7. Severe liver and kidney dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in auditory brainstem re-sponse (ABR);Change from Baseline in pure tone audiometry (PTA);Change from Baseline in auditory steady-state response (ASSR); | — |
Secondary
| Measure | Time frame |
|---|---|
| change from baseline in tinnitus handicap inventory;change from baseline in dizziness handicap inventory;change from baseline in quality of life score;video head impulse data;Change from Baseline in Speech Discrimination Scores;oVEMP;cVEMP; | — |
Countries
China
Contacts
Public ContactShu Yilai, Li Huawei, Wang Wuqing
Eye & ENT hospital of Fudan University
Outcome results
None listed