NCT02353650Unknown不适用
The Effect of Coenzyme Q10 on Hearing and Tinnitus Characteristics of Chronic Tinnitus Patients
适应症
试验速览
- 阶段
- 不适用
- 试验地点
- 1
- 主要终点
- Tinnitus Functional Index
研究概览
简要总结
The study is a randomised double-blinded trial. A group of 40 tinnitus patients with a naturally low Q10 level will be selected out of a preselected group of 160 screened out of a pre-existed database or patients which visited the ENT-consultation. The 40 patients with the lowest level will be asked to take 2 months Q10 (n=20) or the placebo (n=20). To evaluate the effect on hearing and tinnitus characteristic; audiometric test, tinnitus analysis and auditory evoked responses will be used as outcome measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •chronic non-pulsatile tinnitus > 3 months
- •tinnitus has a clear otological cause
- •age > 18 years
排除标准
- •pulsatile tinnitus
- •persons who take already Q10
- •pregnancy
- •cervical tinnitus
- •holocranial tinnitus
- •depression
- •mental of neurological disorders
- •history of chemotherapy
- •middle ear diseases
结局指标
主要结局
Tinnitus Functional Index
时间窗: 2 months
次要结局
- Hyperacusis Questionnaire(2 months)
- Audiometric tresholds test(2 months)
- Tinnitus Analysis _ loudness matches(2 months)
- Tinnitus Analysis_Minimal masking level(2 months)
- Visual Analogue Scale of loudness(2 months)
- Hospital Anxiety and Depression Scale(2 months)
研究者
Ethisch Comité UZA
Ethics Committee
University Hospital, Antwerp
研究点 (1)
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