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Search / Trial NCT07134075

Intracochlear Injection of Glucocorticoid

Launched by EYE & ENT HOSPITAL OF FUDAN UNIVERSITY · Aug 14, 2025

Trial Information

Current as of November 14, 2025

Not yet recruiting

Keywords

Intracochlear Injection Glucocorticoid

ClinConnect Summary

This clinical trial is studying a new treatment for people who suddenly lose hearing in one ear without a clear cause, a condition known as sudden sensorineural hearing loss (SSNHL). The study is testing whether injecting a steroid medicine directly into the inner ear can safely help improve hearing when standard treatments haven’t worked after two weeks. The goal is to see if this approach can be a helpful "rescue" treatment for those with severe hearing loss.

To be eligible, participants need to be between 18 and 65 years old and have experienced a sudden, severe hearing loss in one ear that has not improved after 14 days of usual treatment. People with hearing loss caused by other known conditions, those with hearing loss in both ears, or those with certain medical problems like recent strokes or serious liver or kidney issues would not be able to join. If chosen for the study, participants will receive the steroid injection through a small opening near the ear and will be closely monitored to check for safety and any improvement in hearing. This study is still in the early stages and has not started recruiting patients yet.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 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 The CT diagnosis is "abnormality of the round window niche"

About Eye & Ent Hospital Of Fudan University

The Eye & ENT Hospital of Fudan University is a leading clinical research institution dedicated to advancing the fields of ophthalmology and otolaryngology. With a commitment to innovative medical practices and patient-centered care, the hospital integrates cutting-edge research with clinical expertise to conduct comprehensive clinical trials. Leveraging a multidisciplinary approach, the institution aims to enhance treatment modalities and improve patient outcomes through rigorous scientific investigation and collaboration with academic and industry partners. Its state-of-the-art facilities and experienced team of professionals position the Eye & ENT Hospital of Fudan University as a pivotal contributor to medical advancements in eye and ear, nose, and throat health.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Trial Officials

Yilai Shu, MD, Ph.D

Principal Investigator

Eye & ENT Hospital, Fudan University, Shanghai, China

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported