Prevention of Noise-induced Damage by Use of Antioxidants
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Protection against noise-induced tinnitus due to antioxidants
研究概览
简要总结
The current study is a dubble-blinde placebo-controlled cross-over study verifying the preventive effect of antioxidants on noise-induced hearing loss (NIHL) and noise-induced tinnitus (NIT). The antioxidants comprise of a mixture of magnesium and n-acetylcystein which should be taken 1h before leisure noise above 100dB for at least 30 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-25 years old
- •Temporary tinnitus after noise exposure: loudness >5 on a VAS
排除标准
- •middle ear problems
- •Allergy for magnesium or n-acetylcystein
- •Use of hearing protection when going out
研究组 & 干预措施
Antioxidantia
Dosage: 600mg n-acetylcystein and 200mg magnesium intake: 1 hour before leisure noise exposure above 100dB of at least 30 minutes frequency: 4 separate events (2x placebo, 2x antioxidants)
干预措施: Antioxidantia (Drug)
结局指标
主要结局
Protection against noise-induced tinnitus due to antioxidants
Antioxidants protect against temporary threshold shift. The most prevalent cause of noise-induced tinnitus is noise-induced hearing loss. Therefore, it is assumed that the preventive intake of antioxidants prior to a loud event, might protect against threshold shift as well as noise-induced tinnitus. A 50% decrease of tinnitus loudness scored on a Visual Analogue Scale (VAS) compared to placebo trials is expected.
次要结局
- Change of tinnitus duration
研究者
Ethisch Comité UZ Antwerpen
Ethics Comittee UZ Antwerpen
University Hospital, Antwerp