Department of Emergency Medicine, University of Pittsburgh, School of Medicine, 3600 Forbes Ave., Iroquois Building, Suite 400A, Pittsburgh, PA, 15261, USA.
Division of Community Health Services, Emergency Medicine Program, University of Pittsburgh, School of Health and Rehabilitation Sciences, Pittsburgh, PA, 15261, USA.
Trials. 2021 Mar 16;22(1):212. doi: 10.1186/s13063-021-05161-4.
There is an emerging body of evidence that links exposure to shift work to cardiovascular disease (CVD). The risk of coronary events, such as myocardial infarction, is greater among night shift workers compared to day workers. There is reason to believe that repeated exposure to shift work, especially night shift work, creates alterations in normal circadian patterns of blood pressure (BP) and heart rate variability (HRV) and that these alterations contribute to increased risk of CVD. Recent data suggest that allowing shift workers to nap during night shifts may help to normalize BP and HRV patterns and, over time, reduce the risk of CVD. The risk of CVD related to shift work is elevated for emergency medical services (EMS) shift workers due in part to long-duration shifts, frequent use of night shifts, and a high prevalence of multiple jobs.
We will use a randomized crossover trial study design with three study conditions. The targeted population is comprised of EMS clinician shift workers, and our goal enrollment is 35 total participants with an estimated 10 of the 35 enrolled not completing the study protocol or classified as lost to attrition. All three conditions will involve continuous monitoring over 72 h and will begin with a 36-h at-home period, followed by 24 total hours in the lab (including a 12-h simulated night shift), ending with 12 h at home. The key difference between the three conditions is the intra-shift nap. Condition 1 will involve a simulated 12-h night shift with total sleep deprivation. Condition 2 will involve a simulated 12-h night shift and a 30-min nap opportunity. Condition 3 will involve a simulated 12-h night shift with a 2-h nap opportunity. Our primary outcomes of interest include blunted BP dipping and reduced HRV as measured by the standard deviation of the inter-beat intervals of normal sinus beats. Non-dipping status will be defined as sleep hours BP dip of less than 10%.
Our study will address two indicators of cardiovascular health and determine if shorter or longer duration naps during night shifts have a clinically meaningful impact.
ClinicalTrials.gov NCT04469803 . Registered on 9 July 2020.
有越来越多的证据表明,轮班工作与心血管疾病(CVD)有关。与白班工人相比,夜班工人发生冠状动脉事件(如心肌梗死)的风险更高。有理由相信,反复暴露于轮班工作中,尤其是夜班工作,会改变正常的血压(BP)和心率变异性(HRV)昼夜节律模式,而这些改变会增加 CVD 的风险。最近的数据表明,允许轮班工人在夜班期间小睡可能有助于使 BP 和 HRV 模式正常化,并随着时间的推移降低 CVD 的风险。由于工作时间长、频繁使用夜班以及多种工作的高患病率,急救医疗服务(EMS)轮班工人与轮班工作相关的 CVD 风险升高。
我们将使用随机交叉试验研究设计,有三种研究条件。目标人群是 EMS 临床医生轮班工人,我们的目标入组人数为 35 人,预计其中 10 人无法完成研究方案或被归类为失访。所有三种情况都将涉及 72 小时的连续监测,从 36 小时的在家期开始,然后在实验室总共 24 小时(包括 12 小时的模拟夜班),最后在家 12 小时结束。三种情况的主要区别在于班内小睡。条件 1 将包括模拟 12 小时的夜班,总睡眠时间不足。条件 2 将包括模拟 12 小时的夜班和 30 分钟的小睡机会。条件 3 将包括模拟 12 小时的夜班和 2 小时的小睡机会。我们感兴趣的主要结果包括测量正常窦性心跳间隔的标准差来衡量的 BP 下降变钝和 HRV 降低。非下降状态定义为睡眠时间 BP 下降小于 10%。
我们的研究将解决心血管健康的两个指标,并确定夜间小睡时间长短是否对夜班工作有临床意义的影响。
ClinicalTrials.gov NCT04469803. 于 2020 年 7 月 9 日注册。