P Daniel Patterson1,2, Leonard S Weiss3, Matthew D Weaver4,5, David D Salcido3, Samantha E Opitz3, Tiffany S Okerman3,6, Tanner T Smida3, Sarah E Martin3, Francis X Guyette3, Christian Martin-Gill3, Clifton W Callaway3. 1. Department of Emergency Medicine, University of Pittsburgh, School of Medicine, 3600 Forbes Ave., Iroquois Building, Suite 400A, Pittsburgh, PA, 15261, USA. pdp3@pitt.edu. 2. Division of Community Health Services, Emergency Medicine Program, University of Pittsburgh, School of Health and Rehabilitation Sciences, Pittsburgh, PA, 15261, USA. pdp3@pitt.edu. 3. Department of Emergency Medicine, University of Pittsburgh, School of Medicine, 3600 Forbes Ave., Iroquois Building, Suite 400A, Pittsburgh, PA, 15261, USA. 4. Division of Sleep and Circadian Disorders, Brigham and Women's Hospital, Boston, MA, 02115, USA. 5. Harvard Medical School, Division of Sleep Medicine, Boston, MA, 02115, USA. 6. Division of Community Health Services, Emergency Medicine Program, University of Pittsburgh, School of Health and Rehabilitation Sciences, Pittsburgh, PA, 15261, USA.
Abstract
BACKGROUND: 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. METHODS: 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%. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT04469803 . Registered on 9 July 2020.
RCT Entities:
BACKGROUND: 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. METHODS: 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%. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT04469803 . Registered on 9 July 2020.
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