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Purpose: Poor sleep quality in intensive care unit (ICU) can be associated with poor outcome. Excessive noise and lights in ICU are known to disrupt patients' sleep by causing arousals. Study design: A prospective randomized controlled study. Materials and methods: The patients admitted to the medical ICU were prospectively included and randomized to receive earplugs and eye masks or no intervention during their first 5 nights in ICU. Their arousal index and other sleep parameters were measured during the first night by polysomnography. Secondary outcomes including wrist actigraphy profiles and subjective sleep quality were recorded during all study nights. Results: Seventeen patients were enrolled. Eight patients were randomized to earplugs and eye masks group and nine patients were randomized to control group during their first 5 nights in the ICU. The use of earplugs and eye masks demonstrated the trend toward lower arousal index during the first night (21.15 (14.60) vs 42.10 (18.20) events per hour, p = 0.086) and increased activity index (activity count/hour) (16.12 (7.99) vs 10.84 (10.39) count/hour, p = 0.059) compared to control group. Polysomnography and actigraphy did not demonstrate good agreement. Conclusion: The use of earplugs and eye masks has a trend toward reduction in arousal index and increased activity in patients admitted to ICU. Limited sample size most likely explained insignificant difference in outcomes. Wrist actigraphy did not accurately measure sleep parameters in ICU patients. [ABSTRACT FROM AUTHOR]

Background: Effective anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) drugs are not only the next defense after vaccines but also the key part of establishing a multi-tiered coronavirus disease 2019 (COVID-19) prevention and control system. Previous studies had indicated that Lianhua Qingwen (LHQW) capsules could be an efficacious Chinese patent drug for treating mild to moderate COVID-19. However, pharmacoeconomic evaluations are lacking, and few trials have been conducted in other countries or regions to evaluate the efficacy and safety of LHQW treatment. So, this study aims to explore the clinical efficacy, safety, and economy of LHQW for treating adult patients with mild to moderate COVID-19., Methods: This is a randomized, double-blind, placebo-controlled, international multicenter clinical trial protocol. A total of 860 eligible subjects are randomized at a 1:1 ratio into the LHQW or placebo group to receive two-week treatment and follow-up visits on days 0, 3, 7, 10, and 14. Clinical symptoms, patient compliance, adverse effects, cost scale, and other indicators are recorded. The primary outcomes will be the measured median time to sustained improvement or resolution of the nine major symptoms during the 14-day observation period. Secondary outcomes regarding clinical efficacy will be evaluated in detail on the basis of clinical symptoms (especially body temperature, gastrointestinal symptoms, smell loss, and taste loss), viral nucleic acid, imaging (CT/chest X-ray), the incidence of severe/critical illness, mortality, and inflammatory factors. Moreover, we will assess health care cost, health utility, and incremental cost-effectiveness ratio (ICER) for economic evaluation., Discussion: This is the first international multicenter randomized controlled trial (RCT) of Chinese patent medicine for the treatment of early COVID-19 in accordance with WHO guidelines on COVID-19 management. This study will help clarify the potential efficacy and cost-effectiveness of LHQW in the treatment of mild to moderate COVID-19, facilitating decision-making by healthcare workers., Registration: This study is registered at the Chinese Clinical Trial Registry, with registration number: ChiCTR2200056727 (date of first registration: 11/02/2022)., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-23-281/coif). NSZ serves as Editor-in-Chief of Journal of Thoracic Disease. All authors report that this trial is financially supported by Shijiazhuang Yiling Pharmaceutical Co. Ltd. NSZ, ZFY, and JPZ also report funding from National Administration of Traditional Chinese Medicine (No. ZYYCXTU-D-202206). The authors have no other conflicts of interest to declare., (2023 Journal of Thoracic Disease. All rights reserved.)