Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- THI - Tinnitus Handicap Inventory
研究概览
简要总结
Tinnitus is defined as the perception of sound in the absence of a external source. About 15 % of the population is believed to experience tinnitus and for about 20 % of them it may become a very serious problem. Total comprehension of tinnitus pathophysiology has not yet been achieved, but modern theories focus in brain hyperactivity following inner ear damage, with involvement of various neurotransmitters. Piribedil,a dopamin agonist, has been used to treat tinnitus, focusing in dopamine release, which is inhibitory. Electrophysiological methods,like acoustic otoemissions and electrocochleography may reveal the changes in peripherical and central auditory pathways and help to choose the specific patients who could benefit from piribedil treatment.
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
- Triple (Participant, Care Provider, Investigator)
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
- •tinnitus for more than 6 months
- •THI > 38
- •no central acting drugs in the last 6 months
- •tympanogram type A-n
排除标准
- •vascular and muscular tinnitus
- •concomitant TMJ disorders
- •abnormal otoscopy
- •mixed and conductive hearing losses
结局指标
主要结局
THI - Tinnitus Handicap Inventory
时间窗: Months 3 and 6
次要结局
- VAS - Visual Analog Scale(Months 3 and 6)
