NCT05455398Unknown不适用
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2021年4月1日最近更新:
适应症
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.
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
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
STUDY TO ASSESS HEARING LOSS IN PATIENTS RECEIVING SIMULTANEOUS CHEMOTHERAPY AND RADIATION THERAPY FOR HEAD AND NECK CANCERSCTRI/2014/08/004940FATHER MULLER MEDICAL COLLEGE50
进行中（未招募）
不适用
?Idiopathic sudden sensorineural hearing loss treatment by Infliximab injection (TNF-alfa blocker)? - NDEUCTR2007-004074-10-ITPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Unknown
早期 1 期
Small Sample，Unicentric，Randomized, Controlled Clinical Study of Coenzyme I for Injection in the Treatment of Sudden Sensorineural Hearing LossSudden Sensorineural Hearing LossNCT05849519Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University36
终止
不适用
Hyperbaric oxygen for hearing loss and tinnitusACTRN12609000619246Michael Bennett225
已完成
不适用
The Acoustic Change Complex in normal hearing adults and adults with sensorineural hearing lossDeafness10019243Hearing LossNL-OMON45183niversitair Medisch Centrum Utrecht48