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Not yet recruiting Phase 2 NCT07540728

Trans-round Window Membrane Intracochlear Steroid

Phase 2 – studying effectiveness and dosage
Conditions: Sudden Hearing Loss

Sponsor: Eye & ENT Hospital of Fudan University

trial.available_in: БГ
Overview
Safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with profound or complete sudden sensorineural hearing loss
Description
The main questions it aims to answer are: 1. Whether is it safe when profound or complete sudden sensorineural hearing loss patients receive intracochlear injection of glucocorticoid through the round window membrane. 2. Whether is it effective in reversing hearing capability when profound or complete sudden sensorineural hearing loss patients receive intracochlear injection of glucocorticoid through the round window membrane. 3. Whether is intracochlear glucocorticoid injection more effective than intratympanic glucocorticoid injection for treating profound or complete sudden sensorineural hearing loss. 4. Which glucocorticoid intracochlear injection is more effective in patients with profound or complete sudden sensorineural hearing loss.
Who can participate
Inclusion Criteria: * Age between 12 and 75 years Unilateral idiopathic sudden sensorineural hearing loss diagnosed by Pure tone test, CT and MRI Symptoms of sudden deafness occur within ≥ 7 days and, after conventional treatment, the average thresholds at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz are ≥ 80 dBHL Exclusion Criteria: * Bilateral sudden sensorineural hearing loss Hearing loss with known causes (e.g., Meniere's disease, retrocochlear pathology, history of otologic surgery, perilymphatic fistula, barotrauma) History in the past 6 months of ototoxic treatment such as chemotherapy, use of loop diuretics, high dose aspirin, etc. History of sudden sensorineural hearing loss within the past 2 years History of ischemic diseases (cerebral infarction, myocardial infarction, peripheral arterial obstructive disease) Neuropsychiatric disorders (epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis) Severe hepatic or renal insufficiency
Interventions
Experimental: Group A: intracochlear triamcinolone acetonide injection
DRUG
intracochlear injection of dexamethasone
DRUG
intratympanic dexamethasone injection
DEVICE
Locations 1
China (1)
Fenyang Road 83
Shanghai , Shanghai Municipality
Technical details
Status
Not yet recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
20.04.2026
Completion date
01.05.2028
Registry ID
NCT07540728
Source
clinicaltrials.gov
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