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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
intracochlear triamcinolone acetonide injection of through the round window membrane
intracochlear injection of dexamethasone sodium phosphate through the round window membrane
intracochlear dexamethasone sodium phosphate injection of through the round window membrane, intratympanic dexamethasone sodium phosphate injection through the tympanic membrane
Fenyang Road 83
Shanghai, Shanghai Municipality, China
Change from Baseline in pure tone audiometry (PTA)
hearing capacity of thresholds (PTA)
Time frame: Baseline, Week 2, Week 4, Week12, Week24
Change from Baseline in auditory brainstem response (ABR)
hearing capacity of thresholds (ABR)
Time frame: Baseline, Week 2, Week 4, Week12, Week24
Change from Baseline in auditory steady state response (ASSR)
hearing capacity of thresholds (ASSR)
Time frame: Baseline, Week 2, Week 4, Week12, Week24
Change from Baseline in speech Discrimination Scores
hearing capacity of thresholds (speech Discrimination Scores)
Time frame: Baseline, Week 2, Week 4, Week12, Week24
change from baseline in tinnitus handicap inventory
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).
Time frame: Baseline, Week2, Week4, Week12, Week24
change from baseline in dizziness handicap inventory
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).
Time frame: Baseline, Week2, Week4, Week12, Week24
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intratympanic dexamethasone sodium phosphate injection (10mg/ml) through tympanic membrane，once every other day, for a total of 4 injections.
change from baseline in quality of life score
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.
Time frame: Baseline, Week2, Week4, Week12, Week24