Intracochlear Injection of Glucocorticoid

Not Applicable

Not yet recruiting

• Conditions: Sudden Sensorineural Hearing Loss (SSNHL)
• Interventions: Drug: intracochlear triamcinolone acetonide injection; Drug: intracochlear injection of dexamethasone through the round window membrane; Drug: intracochlear dexamethasone injection and intratympanic dexamethasone injection; Drug: intratympanic dexamethasone injection

• Registration Number: NCT07134075
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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 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.

Study Timeline

• Study First Submitted: 2025-07-30
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21
• Study Start: 2025-08-25
• Primary Completion: 2027-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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"

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: intracochlear triamcinolone acetonide injection	intracochlear triamcinolone acetonide injection	intracochlear injection of triamcinolone acetonide through the round window membrane
Group B: intracochlear dexamethasone injection	intracochlear injection of dexamethasone through the round window membrane	intracochlear injection of dexamethasone through the round window membrane
Group C: intracochlear dexamethasone injection and intratympanic dexamethasone injection	intracochlear dexamethasone injection and intratympanic dexamethasone injection	intracochlear injection of dexamethasone through the round window membrane and intratympanic dexamethasone injection through the tympanic membrane
Group D: intratympanic dexamethasone injection	intratympanic dexamethasone injection	intratympanic dexamethasone injection tympanic membrane，once every other day, for a total of 4 injections.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in pure tone audiometry (PTA)	Baseline, Week 2, Week 4, Week12, Week24	hearing capacity of thresholds (PTA)
Change from Baseline in auditory brainstem response (ABR)	Baseline, Week 2, Week 4, Week12, Week24	hearing capacity of thresholds (ABR)
Change from Baseline in auditory steady state response (ASSR)	Baseline, Week 2, Week 4, Week12, Week24	hearing capacity of thresholds (ASSR)
Change from Baseline in speech Discrimination Scores	Baseline, Week 2, Week 4, Week12, Week24	hearing capacity of thresholds (speech Discrimination Scores)

Secondary Outcome Measures

Name	Time	Method
change from baseline in tinnitus handicap inventory	Baseline, Week2, Week4, Week12, Week24	The THI questionnaire includes functional, emotional, and catastrophic subscales. It consists of 25 questions. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).
change from baseline in dizziness handicap inventory	Baseline, Week2, Week4, Week12, Week24	The 25-item self-report Dizziness Handicap inventory (DHI) validated questionnaire that assesses functional, emotional and physical domains. Responses are graded 0 (no), 2 (sometimes) or 4 (yes) with higher scores indicating greater impact of dizziness maximum and maximum score of 100 points (15 minutes).
change from baseline in quality of life score	Baseline, Week2, Week4, Week12, Week24	Quality of life questionnaire will be measured to compare the change in individual's health-related quality of life using face to face Interview for the scores. Higher scores mean better functioning or fewer symptoms.

Trial Locations

Locations (1)

Fenyang Road 83; 🇨🇳 Shanghai, Shanghai, China