Intracochlear Injection of Glucocorticoid

Eye & ENT Hospital of Fudan University

Status and phase: Not yet enrolling; Phase 2

Conditions: Sudden Sensorineural Hearing Loss (SSNHL)

Treatments: Drug: intracochlear injection of dexamethasone through the round window membrane; Drug: intratympanic dexamethasone injection; Drug: intracochlear dexamethasone injection and intratympanic dexamethasone injection; Drug: intracochlear triamcinolone acetonide injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07134075

intracochlear glucocorticoid

82225014 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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"

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 4 patient groups

Group A: intracochlear triamcinolone acetonide injection

Experimental group

Description:

intracochlear injection of triamcinolone acetonide through the round window membrane

Treatment:

Drug: intracochlear triamcinolone acetonide injection

Group B: intracochlear dexamethasone injection

Experimental group

Description:

intracochlear injection of dexamethasone through the round window membrane

Treatment:

Drug: intracochlear injection of dexamethasone through the round window membrane

Group C: intracochlear dexamethasone injection and intratympanic dexamethasone injection

Experimental group

Description:

intracochlear injection of dexamethasone through the round window membrane and intratympanic dexamethasone injection through the tympanic membrane

Treatment:

Drug: intracochlear dexamethasone injection and intratympanic dexamethasone injection

Group D: intratympanic dexamethasone injection

Active Comparator group

Description:

intratympanic dexamethasone injection tympanic membrane，once every other day, for a total of 4 injections.

Treatment:

Drug: intratympanic dexamethasone injection