Safety and Efficacy of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Total Sudden Sensorineural Hearing Loss
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from Baseline in pure tone audiometry (PTA)
研究概览
简要总结
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.
详细描述
The main questions it aims to answer are:
- Whether is it safe when total sudden sensorineural hearing loss patients receive intracochlear injection of glucocorticoid through the round window membrane.
- 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.
- Whether is intracochlear glucocorticoid injection more effective than intratympanic glucocorticoid injection for treating total sudden sensorineural hearing loss.
- Which glucocorticoid intracochlear injection is more effective in patients with total sudden sensorineural hearing loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
single blinded (participant and outcomes assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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"
研究组 & 干预措施
Group A: intracochlear triamcinolone acetonide injection
intracochlear injection of triamcinolone acetonide through the round window membrane
干预措施: intracochlear triamcinolone acetonide injection (Drug)
Group B: intracochlear dexamethasone injection
intracochlear injection of dexamethasone through the round window membrane
干预措施: intracochlear injection of dexamethasone through the round window membrane (Drug)
Group C: intracochlear dexamethasone injection and intratympanic dexamethasone injection
intracochlear injection of dexamethasone through the round window membrane and intratympanic dexamethasone injection through the tympanic membrane
干预措施: intracochlear dexamethasone injection and intratympanic dexamethasone injection (Drug)
Group D: intratympanic dexamethasone injection
intratympanic dexamethasone injection tympanic membrane，once every other day, for a total of 4 injections.
干预措施: intratympanic dexamethasone injection (Drug)
结局指标
主要结局
Change from Baseline in pure tone audiometry (PTA)
时间窗: Baseline, Week 2, Week 4, Week12, Week24
hearing capacity of thresholds (PTA)
Change from Baseline in auditory brainstem response (ABR)
时间窗: Baseline, Week 2, Week 4, Week12, Week24
hearing capacity of thresholds (ABR)
Change from Baseline in auditory steady state response (ASSR)
时间窗: Baseline, Week 2, Week 4, Week12, Week24
hearing capacity of thresholds (ASSR)
Change from Baseline in speech Discrimination Scores
时间窗: Baseline, Week 2, Week 4, Week12, Week24
hearing capacity of thresholds (speech Discrimination Scores)
次要结局
- change from baseline in tinnitus handicap inventory(Baseline, Week2, Week4, Week12, Week24)
- change from baseline in dizziness handicap inventory(Baseline, Week2, Week4, Week12, Week24)
- change from baseline in quality of life score(Baseline, Week2, Week4, Week12, Week24)