DRKS00006050招募中未知
Effect of nocturnal aircraft noise on vascular function in patients with cardiovascular disease o at increased risk thereof
nivesitätsmedizin Mainz0 个研究点目标入组 100 人开始时间: 2014年4月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 30 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Men and women between 30 and 75 years with established cardiovascular diseas or at a Framingham Risk > 10 % (Framingham Heart General CVD Risk , D'Agostino et. al), , who are not exposed to nighttime aircraft noise or other traffic noise exposure > 45 dB at their homes
排除标准
- •Nitrates in medication
- •medication changes in last 4 weeks
- •unstable cardiovascular disease (specified in study protocol)
- •hospitalization in the preceding 4 weeks
- •uncontrolled hypertension > 160/100 mmHg
- •severe cardiac valve stenosis or regurgitation
- •severely depresse LVEF < 30 %
- •renal insufficiency needing dialysis
- •exposure to traffic noise > Leq 45 dB at place of residence
- •sleep disorders (PSQI > 10)
- •positive Screening for obstructive sleep apnea (OSAS)
- •regular sleep duration < 6 hours
- •regular sedative use
- •Epilepsy or psychiatric disorders
- •shift workers
- •hearing loss > 30 dB
- •employees of airports, airline and anti-noise activists
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