Sun Yat-sen Memorial Hospital, Sun Yat-sen University
试验速览
- 阶段
- 不适用
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Establishment of a trans-round window inner ear continuous drug delivery system for the treatment of severe-to-profound sudden sensorineural hearing loss
研究概览
简要总结
The investigators enrolled patients with total sudden deafness who had failed treatment with systemic combined intra-dural hormone injections. The patients were randomly divided into a pilot group and a control group for a randomized controlled clinical study, with the pilot group receiving a round window niche enlargement via round window inner ear administration and the control group receiving regular intra-drum injection hormone therapy
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
- None
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 ≥ 18 years old, ≤ 65 years old
- •The diagnostic criteria for total deafness type of sudden deafness published in 2015 were met, and the patient had sudden, unilateral full-frequency severe or very severe sensorineural deafness with or without deafness, tinnitus, peri-aural numbness, vertigo, and dizziness, and the diagnosis of sudden deafness was supported by physical examination, pure tone audiometry(PTA), acoustic impedance, and auditory brainstem response(ABR). Magnetic resonance(MR) of the internal auditory tract ruled out the occupancy of the internal auditory tract and pontocerebellar region.
- •Those with an onset of ≤ 6 weeks who have received a systemic application of glucocorticoid shock therapy, glucocorticoid intra-drum injections, and medication to improve inner ear circulation, but have not responded to treatment (PTA improvement < 15 dB).
- •No history of middle or inner ear surgery, no history of radiotherapy or chemotherapy; no general anesthesia - contraindication.
- •Patients voluntarily participate in this study and sign an informed consent form
排除标准
- •Bilateral sudden deafness, drug-based deafness, autoimmune diseases, specific infections, syndromic deafness malignant tumors.
- •Pregnant and lactating women.
- •Cannot tolerate general anesthesia surgery, and severe liver and kidney dysfunction.
- •Any other conditions that the investigator believes should be excluded from this study.
研究组 & 干预措施
Round window niche enlargement group
The round window niche was surgically removed by general anesthesia, the round window membrane was opened as entirely as possible, and the blockage of the round window membrane was carefully identified.
干预措施: Surgical treatment of round window niche enlargement via round window for inner ear drug delivery (Procedure)
Drum chamber injection group
Methylprednisolone (40 mg) was injected via puncture in the posterior quadrant of the tympanic membrane once daily for 7 d. Patients were instructed to remain supine for 30 min to keep the drug in the tympanic chamber and to avoid swallowing to prevent drug flow from the eustachian tube.
干预措施: Drum chamber drug injection (Procedure)
结局指标
主要结局
Establishment of a trans-round window inner ear continuous drug delivery system for the treatment of severe-to-profound sudden sensorineural hearing loss
时间窗: up to one year
Assessment of post-operative hearing improvement by pure tone audiometry
次要结局
未报告次要终点