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Starting soon Phase 2

Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss

NCT07814677 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-09-15
Last updated
2026-09-11

Condition(s) studied

Sudden Hearing Loss

Investigational drug(s) / intervention(s)

intracochlear injection of triamcinolone acetonide through the round window membraneintratympanic dexamethasone injection through the tympanic membrane

intracochlear injection of triamcinolone acetonide through the round window membrane: intracochlear injection of triamcinolone acetonide through the round window membrane

intratympanic dexamethasone injection through the tympanic membrane: intratympanic dexamethasone injection through the 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 The CT diagnosis is "abnormality of the round window niche".

Primary outcome measure(s)

  • Change from Baseline in pure tone audiometry (PTA) — Baseline , Week2 , Week4, Week12, Week24.
    hearing capacity of thresholds ( PTA)
  • Change from Baseline in Speech Discrimination Scores — Baseline , Week4, Week12, Week24.
    hearing capacity of thresholds ( speech discrimination )

Trial sites (1)

FacilityCityRegionStatus
Eye and ENT Hospital, Fudan University Shanghai Shanghai Municipality
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 NCT07814677 on ClinicalTrials.gov ↗ ← All trials in China