Trans-round Window Membrane Intracochlear Steroid

Phase 2Not Yet RecruitingNCT07540728

Eye & ENT Hospital of Fudan University108 enrolled

Overview

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

The main questions it aims to answer are: 1. Whether is it safe when profound or complete 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 profound or complete 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 profound or complete sudden sensorineural hearing loss. 4. Which glucocorticoid intracochlear injection is more effective in patients with profound or complete sudden sensorineural hearing loss.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

108

Conditions

Sudden Hearing Loss

Interventions

Experimental: Group A: intracochlear triamcinolone acetonide injectionDRUG

intracochlear injection of triamcinolone acetonide through the round window membrane

intracochlear injection of dexamethasoneDRUG

intracochlear injection of dexamethasone through the round window membrane

intratympanic dexamethasone injectionDEVICE

intratympanic dexamethasone injection through tympanic membrane

Eligibility

Sex: ALLMin age: 12 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Fenyang Road 83

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Change from Baseline in pure tone audiometry (PTA)

hearing capacity of thresholds ( PTA)

Time frame: Baseline, Week12,

Change from Baseline in Speech Discrimination Scores

hearing capacity of thresholds ( speech discrimination )

Time frame: Baseline, Week12

Secondary Outcomes

Change from Baseline in auditory brainstem re-sponse (ABR)

hearing capacity of thresholds ( ABR)

Time frame: Baseline, Week12

Change from Baseline in auditory steady-state response (ASSR)

hearing capacity of thresholds (ASSR)

Time frame: Baseline, Week12

change from baseline in tinnitus handicap inventory

The scales assess changes in vertigo

Time frame: Baseline, Week2, Week4, Week12, Week24

change from baseline in dizziness handicap inventory

The scales assess changes in vertigo

Time frame: Baseline, Week2, Week4, Week12, Week24

change from baseline in quality of life score

The scales assess changes in quality of life

Time frame: Baseline, Week2, Week4, Week12, Week24

Central Contacts

Wei Li, MD, Ph.D

CONTACT

0086-18301969566 619liwei@163.com

Data from ClinicalTrials.gov

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