NCT01253616已完成不适用
A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Audiometric measurements
研究概览
简要总结
This is a proof-of-concept study designed to provide feasibility information on the clinical use of vagus nerve stimulation (VNS) paired with tones for the treatment of severe tinnitus. The study is expected to give preliminary efficacy and safety information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years of age
- •Diagnosed with subjective tinnitus due to hearing loss with at least some tonal quality of the tinnitus.
- •Diagnosis of tinnitus for at least one year
- •Tinnitus severity of 18 or greater on TRQ cross checked with TQ severity of Grade 3 or worse
排除标准
- •Acute or intermittent tinnitus
- •Severe hearing loss
- •History of significant ear disease such as Meniere's disease, ear tumors, or evidence of active middle ear disease.
- •Any other implanted device
结局指标
主要结局
Audiometric measurements
时间窗: weekly through one month
次要结局
- tinnitus questionaires(weekly through one month)
- adverse events(as they occur)
研究者
研究点 (2)
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