NCT04069364Unknown不适用
Systematische Untersuchung Zum Einfluss Von Selbsthilfe Auf Die Subjektive Belastung Bei Chronischem Tinnitus
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of Tinnitus Numeric Rating Scale
研究概览
简要总结
With this study we want to investigate the impact of self-help tools on the subjective tinnitus distress in chronic tinnitus patients.
Furthermore, we want to investigate the influence of personal characteristics on the individual tinnitus improvement.
详细描述
A smart-phone app running on iOS devices will be used to give self-help tips to the chronic tinnitus patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- 是
入选标准
- •chronic tinnitus, duration at least 6 monhts
排除标准
- •acute psychosis, depression, substance abuse
- •psychopharmaca
- •epilepsy or other disease of the central nervous system
- •other tinnitus treatments in the last 3 months
- •drug, medication or alcohol abuse in the last 12 weeks
结局指标
主要结局
Change of Tinnitus Numeric Rating Scale
时间窗: Before, after 4 months, and after 6 months
Questionnaire
Change of Tinnitus Handicap Inventory
时间窗: Before, after 4 months, and after 6 months
Questionnaire
Change Clinical Global Impression
时间窗: Before, after 4 months, and after 6 months
Questionnaire
次要结局
- Change of WHO Quality of Life(Before, after 4 months, and after 6 months)
研究者
Winfried Schlee
Head of eHealth Group
University Hospital Regensburg
研究点 (1)
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