Efficacy and Safety of Trans-Round Window Membrane Intracochlear Steroid Delivery in Patients With Complete Sudden Sensorineural Hearing Loss
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change from Baseline in Speech Discrimination Scores
研究概览
简要总结
Safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with profound or complete sudden sensorineural hearing loss
详细描述
The main questions it aims to answer are:
- Whether is it safe when profound or complete sudden sensorineural hearing loss patients receive intracochlear injection of glucocorticoid through the round window membrane.
- 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.
- Whether is intracochlear glucocorticoid injection more effective than intratympanic glucocorticoid injection for treating profound or complete sudden sensorineural hearing loss.
- Which glucocorticoid intracochlear injection is more effective in patients with profound or complete sudden sensorineural hearing loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
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
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: Experimental: Group A: 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 (Drug)
Group C: intratympanic dexamethasone injection
intratympanic dexamethasone injection through tympanic membrane
干预措施: intratympanic dexamethasone injection (Device)
结局指标
主要结局
Change from Baseline in Speech Discrimination Scores
时间窗: Baseline, Week12
hearing capacity of thresholds ( speech discrimination )
Change from Baseline in pure tone audiometry (PTA)
时间窗: Baseline, Week12,
hearing capacity of thresholds ( PTA)
次要结局
- Change from Baseline in auditory brainstem re-sponse (ABR)(Baseline, Week12)
- Change from Baseline in auditory steady-state response (ASSR)(Baseline, Week12)
- 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)