P Daniel Patterson, Cassie J Hilditch, Sarah E Martin, David G L Roach, Matthew D Weaver, Tiffany S Okerman, David Hostler, Leonard S Weiss, Steven E Reis
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引用次数: 0
Abstract
Background: Night shift workers face increased risk of cardiovascular disease (CVD) compared to non-shift workers. Evidence supports on-shift napping and regular non-invasive monitoring of endothelial function for risk mitigation, yet neither strategy is widely used.
Methods: We evaluated the feasibility of non-invasive assessment of peripheral arterial tone (PAT) to assess the effect of napping during simulated night shift work on endothelial function. We used a single-site, randomized crossover trial of simulated night shift work with a 45-min nap condition versus a control, no-nap condition (ClinicalTrials.gov NCT05436951).
Results: The primary outcome was the number of participants with ≥ 70% of endothelial function assessments. Secondary outcomes included mean reactive hyperemia index (RHI), BP, and cognitive performance with the brief psychomotor vigilance task (PVT-B). Of the 10 consented, 9 completed both conditions. All participants exceeded feasibility benchmarks. Mean RHI did not differ by nap condition, and the delta from pre- to post measure did not differ (difference in delta = - 0.26, 95% CI - 1.09, 0.58). Hourly PVT-B assessments from 19:00 to 07:00 h did not differ by nap condition. Compared to pre-nap measures, cognitive performance on the PVT-B was poorest at + 0 min post-nap.
Conclusion: Our findings can inform larger studies evaluating the effects of night shift work and napping on endothelial function.
Trial registrations: ClinicalTrials.gov (NCT05436951, registered on June 23, 2022).
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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