Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Hearing thresholds
研究概览
简要总结
The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation
详细描述
Many efforts have been made to prevent residual hearing loss after cochlear implantation, such as the development of soft surgical techniques and pharmacological protection.
In this study we investigate whether the topical application of dexamethasone and hyaluronic acid prevents residual 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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (greater than 18 years old) with severe/profound, bilateral sensorineural hearing loss with indication of cochlear implantation.
- •Hearing thresholds better than 80 dB in 125 Hz, 90 dB in 250Hz and 100 dB in 500, 1000, 2000, 3000 and 4000 Hz in at least 3 of these frequencies
排除标准
- •Malformation or cochlear ossification
- •Developmental Disabilities
研究组 & 干预措施
Control group
Cochlear Implantation
干预措施: Cochlear Implantation (Device)
Dexamethasone
Cochlear implantation using topical dexamethasone
干预措施: Cochlear Implantation (Device)
Dexamethasone
Cochlear implantation using topical dexamethasone
干预措施: Cochlear Implantation+dexamethasone (Drug)
Dexamethasone+Hyaluronic acid
Cochlear implantation using topical dexamethasone associated with hyaluronic acid
干预措施: Cochlear Implantation (Device)
Dexamethasone+Hyaluronic acid
Cochlear implantation using topical dexamethasone associated with hyaluronic acid
干预措施: Cochlear Implantation+dexamethasone+hyaluronic acid (Drug)
结局指标
主要结局
Hearing thresholds
时间窗: within the first 6 months after surgery
Hearing thresholds will be measured by audiometry in the frequencies 125, 250, 500, 1000, 2000 and 4000 Hz in the preoperatory, 1 month, 3 months and 6 months after the surgery.
次要结局
未报告次要终点