Acetylcystein Vid Stapedotomi
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 3
- 主要终点
- Hearing thresholds
研究概览
简要总结
In otosclerosis, one of the tiny bones of the middle ear is unable to move normally. Sounds cannot be transferred to the inner ear and a conductive hearing loss ensues. The disorder is usually treated by an operation where the bone is replaced by a prosthesis. This restores hearing at low sound frequencies. At high frequencies, surgery is less effective. The smaller effect at high frequencies is probably caused by surgically induced inner ear damage.
Animal studies have shown that the drug acetylcysteine can protect the inner ear against damage. It is not known whether the drug has similar effects in humans. This study will assess the efficacy of acetylcysteine in patients undergoing surgery for otosclerosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Otosclerosis where surgery is planned
- •Air / bone gap larger than 20 dB
- •Normal middle ear status
排除标准
- •Hypersensitivity to acetylcysteine
- •Deafness on the other ear
- •Stapedotomy previously performed on the ear
- •Pregnancy
研究组 & 干预措施
1
干预措施: Acetylcysteine (Drug)
2
干预措施: Placebo (NaCl) (Drug)
结局指标
主要结局
Hearing thresholds
时间窗: one year
次要结局
未报告次要终点
研究者
Anders Fridberger
Dr.
Karolinska University Hospital