NCT07134075

Intracochlear Injection of Glucocorticoid

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 sensorineural hearing loss safety and efficacy in total sudden sensorineural hearing loss patients as an early salvage therapy.

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 membrane. 2. Whether is it effective in reversing hearing capability when total 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 total sudden sensorineural hearing loss. 4. Which glucocorticoid intracochlear injection is more effective in patients with total sudden sensorineural hearing loss.

Conditions

• Sudden Sensorineural Hearing Loss (SSNHL)

Interventions

Type	Name	Description
DRUG	intracochlear triamcinolone acetonide injection	intracochlear triamcinolone acetonide injection of through the round window membrane
DRUG	intracochlear injection of dexamethasone through the round window membrane	intracochlear injection of dexamethasone sodium phosphate through the round window membrane
DRUG	intracochlear dexamethasone injection and intratympanic dexamethasone injection	intracochlear dexamethasone sodium phosphate injection of through the round window membrane, intratympanic dexamethasone sodium phosphate injection through the tympanic membrane
DRUG	intratympanic dexamethasone injection	intratympanic dexamethasone sodium phosphate injection (10mg/ml) through tympanic membrane，once every other day, for a total of 4 injections.

Timeline

• Start date: 2025-08-25
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-08-21
• Last updated: 2025-08-21

Locations

1 site across 1 country: China