NCT01435317已完成4 期
Prospective Clinical Study for Confirmation of Efficacy and Safety of Acoustic CR®-Neuromodulation by CE Marked ANM T30 CR®-System in a "Real Life" Patient Population With Chronic Tonal Tinnitus
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 46
- 主要终点
- Improvement of TBF-12 Score or CGI Score
研究概览
简要总结
Confirmation of efficacy and safety of acoustic CR®-neuromodulation for the treatment of chronic tinnitus patients using the CE marked ANM T30 CR®-system in a real life outpatient setting.
- Identification of early indicators for therapy success
- Comparison of different patient groups regarding: tinnitus severity, tinnitus duration, level of hearing loss, stimulation patterns, unilateral monotonal vs. all other complex forms
- Representative set of safety data in a broad patient spectrum
- Measurement of tinnitus burden (TBF-12 Questionnaire)
- Generation of longterm compliance data
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic subjective tonal chronical (> 3 months) tinnitus
- •<60dB hearing loss
- •men and women ≥18 years old
排除标准
- •serious neurologic
- •psychiatric or internistic disease
- •objective tinnitus
- •Morbus Menière
- •craniomandibular triggered tinnitus
结局指标
主要结局
Improvement of TBF-12 Score or CGI Score
时间窗: 12 months
Change of tinnitus severity, measured by TBF-12 Score or CGI score change from baseline to end of treatment.
次要结局
- Tinnitus-freedom(3,6,9,12 months)
- Compliance(0.5,1,3,6,9,12 months)
- Audiogram for hearing loss change(3,12 months)
- TBF-12(3,6,9,12 months)
- Alteration of tinnitus(0.5,1,2,3,6,9,12 months)
- NRS loudness and annoyance (0-100)(0.5, 1, 2, 3, 6, 9, 12 months)
研究者
研究点 (46)
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