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临床试验/DRKS00010670
DRKS00010670尚未招募未知

Differential effects of aircraft noise patterns with comparable averaged sound pressure levels on endothelial function in persons at increased cardiovascular risk - FluG-Prime Level

niversitätsmedizin Mainz, Zentrum für Kardiologie0 个研究点目标入组 105 人开始时间: 2016年6月16日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
105

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 with ages ranging from 30 to 75 years with established cardiovascular disease or persons at an increased 10 year risk above 10 % as determined by the Fram-ingham Heart General CVD Risk (D'Agostino et. al), who are not exposed to relevant nocturnal aircraft noise exposure at their primary place of residence. Also they do not have any nighttime noise exposure greater than Leq >45 dB, as determined by municipal noise maps

排除标准

  • Vascular abnormalities or conditions that preclude FMD measurement on arm (dialysis shunt, lypmphedema etc.)
  • History of stroke
  • Patients taking long acting nitrated
  • Any medication changes within the preceding 4 weeks
  • Hearing loss > 30 dB audiometry (age adjusted)
  • Unstable cardiovascular disease (myocardial infarction in the last 3 months, hospitalization within the last 4 weeks, uncontrolled hypertension, history of hypertensive emergency, uncontrolled supraventricular tachycardia (> 120 bpm in case of AF), history of sustained VT, history of sudden cardiac death, severe valvular stenosis or regurgitation, severely reduced left ventricular ejection fraction)
  • Place of residence with nocturnal road traffic noise Leq> 45 dB (municipal noise map city of Mainz)
  • Place of residence with maximum nocturnal aircraft noise Leq3 > 45 dB continuous sound pressure level independent of flight direction (on the basis of data from state of Hessia; www.laermkarten.de)
  • Pathologic PSQI (>10) denoting sleep disorders
  • Evidence of obstructive sleep apnea in screening questionnaire
  • Average daily sleep duration below 6 hours.
  • Current shift work
  • Sedative use (>= 1 dose/ week)
  • Known epilepsy or other neurological or mental disorder for which sleep restriction is contraindicated.
  • pregnancy
  • persons actively involved in anti-aircraft groups are excluded as are employees of air-ports, airlines or other companies with major financial interest in air traffic.

研究者

发起方
niversitätsmedizin Mainz, Zentrum für Kardiologie

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