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
研究组 & 干预措施
Surgical Arm
Surgery arm - patient undergoes tympanomastoidectomy (approx 2 hour operation on ear and mastoid) where a local soft tissue flap is transferred to cover the sigmoid sinus, a cartilage and perichondrial graft is taken from the tragus to cover the jugular bulb).Patient has routine follow up - H&P, 2 weeks after surgery and then H&P, Audiometry and Tympanometry over 12 months post surgery (3rd month, 6th month and 12th month).
干预措施: Tympanomastoidectomy (Procedure)
Non-Surgery
Non surgery arm - patient has audiological consult and fitting of masking device.
The Patient has a routine follow up - H&P, 2 weeks after masking fitting and then H&P, Audiometry, Tympanometry over 12 months (3rd month, 6th month and 12th month). Patient cross over to change arms, at 6 months, if they have no resolution of symptoms.
干预措施: Non-Surgery (Procedure)
Non-Surgery
Non surgery arm - patient has audiological consult and fitting of masking device.
The Patient has a routine follow up - H&P, 2 weeks after masking fitting and then H&P, Audiometry, Tympanometry over 12 months (3rd month, 6th month and 12th month). Patient cross over to change arms, at 6 months, if they have no resolution of symptoms.
干预措施: Tympanomastoidectomy (Procedure)
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