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Clinical Trials in China / NCT07540728
Starting soon Phase 2

Trans-round Window Membrane Intracochlear Steroid

NCT07540728 · tracked via the Priya Life Science China tracker
Sponsor
Eye & ENT Hospital of Fudan University
Phase
Phase 2
Started
2026-04-20
Last updated
2026-04-20

Condition(s) studied

Sudden Hearing Loss

Investigational drug(s) / intervention(s)

Experimental: Group A: intracochlear triamcinolone acetonide injectionintracochlear injection of dexamethasoneintratympanic dexamethasone injection

Experimental: Group A: intracochlear triamcinolone acetonide injection: intracochlear injection of triamcinolone acetonide through the round window membrane

intracochlear injection of dexamethasone: intracochlear injection of dexamethasone through the round window membrane

intratympanic dexamethasone injection: intratympanic dexamethasone injection through tympanic membrane

Study summary

Safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with profound or complete sudden sensorineural hearing loss

Eligibility

Sex
ALL
Min age
12 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change from Baseline in pure tone audiometry (PTA) — Baseline, Week12,
    hearing capacity of thresholds ( PTA)
  • Change from Baseline in Speech Discrimination Scores — Baseline, Week12
    hearing capacity of thresholds ( speech discrimination )

Trial sites (1)

FacilityCityRegionStatus
Fenyang Road 83 Shanghai Shanghai Municipality

More Eye & ENT Hospital of Fudan University trials in China

Penpulimab in Combination With Cetuximab as First-line Treatment in R/M SCCHN Recruiting
Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss Starting soon
Efficacy of Internet-based Cognitive Behavioral Therapy for Insomnia in Patients With Tinnitus and Insomnia Starting soon
JN002 for the Treatment of Dry Eye Disease Recruiting
AR Training Versus Patching in Unilateral Amblyopia Recruiting

Other trials for the same condition

Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss Starting soon
The Effect of PAP on ISSHL Comorbided With OSA Recruiting
Study on the Safety and Efficacy of Intratympanic Injection of Small Extracellular Vesicles Derived From Mesenchymal Stem Cells in Severe and Profound Sudden Sensorineural Hearing Loss Starting soon
Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss Recruiting
Effectiveness of Integrative Medical Treatment in Sudden Hearing Loss Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07540728 on ClinicalTrials.gov ↗ ← All trials in China