EaseAlert: Tactile Firefighter Alerting System Designed to Reduce Negative Cardiovascular Outcomes and Sleep Disturbances

项目摘要 心脏性猝死(SCD)一直是消防部门值班死亡(ODD)的主要原因。 过去几十年，占2019年所有赔率的51.6%。导致SCD的主要因素 消防员中存在过度劳累和应激，SCD最容易发生在灭火和 警报响应。当紧急情况发生时，消防员会被响亮的机械铃声惊醒。这 高噪声水平可能会引发应激反应，从而引发心血管事件。事实上，“高水平的 环境噪音会刺激杏仁核并使动脉发炎，从而增加心脏风险。而其他人 公司曾试图使警报系统现代化，但未能解决压力过大的问题 警报是因为它们专注于向“车站”而不是个别消防员发出警报。存在着开发的重大需求 一种压力较小的消防员警报系统。这项SBIR第一阶段R43研究的目标是 开发商业上可行的消防员警报系统(FFA)，由专有可穿戴设备和 可选的摇床器称为BunkAlerts。可穿戴设备和BunkAlerts统称为“个人警报设备” 通过将刺耳的声音警报替换为传递给 消防员的手腕。这种替代方法旨在显著减少心动过速反应。 与传统警报系统相关联。满足这一需求有可能降低消防员的几率并 改善全球1540万消防员的生活质量。EaseAlert的FFA的可行性 在与三(3)个州的六(6)个消防部门进行现场测试期间收集的初步数据加强了这一点 EaseAlert的原型FFA(第一代)成功地向被召唤到的消防员发送了10,000多个警报 没有未接来电的紧急情况。我们的游离脂肪酸在以下方面降低压力和SCD风险的潜力 消防员的初步数据表明：1)噪音引发惊吓反应；2)触觉 警示与正价和高唤醒有关。拟议的研究将在以下情况下完成 两个目标：目标1--开发一种商业上可行的FFA和目标2--确定FFA在#年的效力 降低心脏反应性，改善睡眠。EaseAlert将利用第1代FFA作为以下目标的基础 开发其在目标1中概述的第二代FFA。目标2将在受试者内试验中测试两项研究假设 临床试验设计：(H2.1)EaseAlert将显著降低对警报的应激反应 与传统的听觉报警系统相比，(H2.2)EaseAlert将带来显著的改进 在睡眠效率方面。在成功完成第一阶段后，我们的第2代FFA和试点试验将展示 第二阶段的技术优势和可行性。第二阶段将进行大型随机平行分组临床试验 有能力检查这一创新警报系统的生理和心理影响 皮质醇(应激)和C反应蛋白等重要生物标志物的长期结果 (炎症)除了睡眠结果和心理功能。

Project Abstract Sudden cardiac death (SCD) has been the leading cause of on-duty death (ODD) in the fire service over the past several decades, accounting for 51.6% of all ODDs in 2019. The primary factors that contribute to SCD among firefighters are overexertion and stress, and SCD is most likely to occur during fire suppression and alarm response. When an emergency occurs, firefighters are alerted/awoken by loud mechanical bells. This high noise level may induce a stress response triggering a cardiovascular event. In fact, “high levels of environmental noise fuel cardiac risk” by stimulating the amygdala and inflaming the arteries. While other companies have attempted to modernize alerting systems, they failed to address the problem of stressful alarms because they focus on alerting “stations” not individual firefighters. A significant need exists to develop a less stressful alerting system for firefighters. The objective for this SBIR Phase I R43 research study is to develop a commercially viable Fire Fighter Alerting System (FFAS) comprised of proprietary wearables and optional bed shakers called BunkAlerts. Collectively “personal alerting devices,” the wearables and BunkAlerts enhance the alerting process for firefighters by replacing jarring audible alarms with tactile alerts delivered to the firefighter's wrist. This alternative approach is designed to significantly decrease tachycardic responses associated with legacy alerting systems. Meeting this need has the potential to reduce firefighter ODDs and improve the quality of life for the 15.4 million firefighters around the world. The feasibility of EaseAlert's FFAS is reinforced by preliminary data collected during field testing with six (6) fire departments in three (3) states where EaseAlert's prototype FFAS (“Gen 1”) successfully delivered over 10,000 alerts to firefighters called to an emergency with no calls missed. The potential for our FFAS to reduce stress and SCD risk among firefighters is supported by preliminary data which shows that: 1) noise triggers a startle response and 2) tactile alerts are associated with positive valence and high arousal. The proposed research will be accomplished with two aims: Aim 1 – develop a commercially viable FFAS and Aim 2 - determine the effectiveness of the FFAS in reducing cardiac reactivity and improving sleep. EaseAlert will leverage the Gen 1 FFAS as a foundation for developing its Gen 2 FFAS outlined in Aim 1. Aim 2 will test two study hypotheses in a within-subjects pilot clinical trial design: (H2.1) that EaseAlert will result in a significant reduction in the stress response to alarms compared to traditional auditory alerting systems, and (H2.2) EaseAlert will result in a significant improvement in sleep efficiency. Upon successful completion of Phase I, our Gen 2 FFAS and pilot trial will demonstrate technical merit and feasibility for Phase II. Phase II will conduct a large randomized parallel groups clinical trial powered to examine the physiological and psychological effects of this innovative alerting system alongside longer-term outcomes for important biological markers such as cortisol (stress) and c-reactive protein (inflammation) in addition to sleep outcomes and psychological functioning.