Surgery Compared to Masking Device for Venous Pulsatile Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change from baseline in patient-reported tinnitus score
研究概览
简要总结
The investigators aim to study whether surgical resurfacing of the sigmoid sinus and jugular bulb will result in elimination of venous pulsatile tinnitus.
详细描述
Currently there is no known treatments with efficacy for venous pulsatile tinnitus without any pathology. The investigators hope to learn that in surgery, resurfacing of the sigmoid sinus and jugular bulb (acoustic dampening) will eliminate symptoms such as pulsatile tinnitus in patients. The knowledge learned will significantly help treat and alleviate future patients that have pulsatile tinnitus.
The purpose of the study is to examine whether surgical resurfacing of the sigmoid sinus and jugular bulb will result in elimination of pulsatile tinnitus in human subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral venous pulsatile tinnitus
- •Visual Analogue score of severity >5
排除标准
- •Surgery exclusion criteria
- •Only hearing ear
- •Unfit for surgery / anesthesia
- •Visual Analogue score of severity 5 or less
结局指标
主要结局
Change from baseline in patient-reported tinnitus score
时间窗: 12 Months
Tinnitus severity rated on a 10-point Likert scale (range: 1-10; higher scores correspond to more severe symptoms).
次要结局
未报告次要终点
研究者
Peter Santa Maria
Assistant Professor
Stanford University