Status:
NOT_YET_RECRUITING
Intracochlear Injection of Glucocorticoid
Lead Sponsor:
Eye & ENT Hospital of Fudan University
Collaborating Sponsors:
Shanghai Zhongshan Hospital
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Conditions:
Sudden Sensorineural Hearing Loss (SSNHL)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is a prospective, randomized pilot study. To verify safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with total sudden sensorin...
Detailed Description
The main questions it aims to answer are: 1. Whether is it safe when total sudden sensorineural hearing loss patients receive intracochlear injection of glucocorticoid through the round window membra...
Eligibility Criteria
Inclusion
- Age between 18 and 65 years Unilateral idiopathic sudden sensorineural hearing loss greater than 95dB at the average of 4 frequencies (500 Hz, 1000 Hz, 2000 Hz and 4000 Hz) in PTA (contralateral hearing is less than 30dB) at the onset of sudden hearing loss Participant who were treated with standard treatment for 14 days, but no recovery was confirmed as type IV (final hearing level with hearing gain of ≤15 dB) at the end of the 14-day treatment
Exclusion
- 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 The CT diagnosis is "abnormality of the round window niche"
Key Trial Info
Start Date :
August 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07134075
Start Date
August 25 2025
End Date
August 1 2027
Last Update
August 21 2025
Active Locations (1)
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1
Fenyang Road 83
Shanghai, Shanghai Municipality, China, 200031