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

EaseAlert：触觉消防员警报系统，旨在减少心血管不良后果和睡眠障碍

• 批准号: 10547460
• 负责人: Joel Billings
• 金额: $ 38.48万
• 依托单位: EASEALERT LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10547460
• 关键词: 911 call; Accounting; Address; Adopted; Amygdaloid structure; Anxiety; Arousal; Arteries; Auditory; Beds; Biological Markers; Blood Pressure; C-reactive protein; Cardiac; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Clinical Trials Cooperative Group; Clinical Trials Design; Computer software; Data; Development; Devices; Drowsiness; Emergency Situation; Emergency medical service; Emergency response; Event; Feedback; Fire - disasters; Foundations; Fright; Future; Health; Hearing; Heart Rate; Hour; Human Resources; Hydrocortisone; Hypersensitivity; Hypertension; Inflammation; Intracranial Pressure; Light; Loudness; Manuals; Measures; Mechanics; Mediating; Modernization; Nervousness; Noise; Notification; Outcome; Participant; Phase; Physiological; Positive Valence; Process; Psychophysiologic Disorders; Quality of life; Randomized; Reporting; Research; Research Personnel; Research Proposals; Risk; Role; Sleep; Sleep disturbances; Small Business Innovation Research Grant; Startle Reaction; Stress; System; Tactile; Testing; Time; Ulcer; Validation; Wrist; awake; biological adaptation to stress; design; effectiveness evaluation; field study; fire fighter; improved; innovation; meetings; mortality risk; nervous system disorder; novel; pilot trial; programs; prototype; psychologic; research study; response; satisfaction; secondary outcome; sleep onset; sudden cardiac death; trial comparing

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.

项目摘要 心源性猝死（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ODD的51.6%。导致SCD的主要因素 在消防员中，过度劳累和压力，SCD最有可能发生在灭火过程中， 警报响应当紧急情况发生时，消防员会被响亮的机械铃声唤醒。这 高噪声水平可诱发触发心血管事件应激反应。事实上，“高水平的 环境噪音通过刺激杏仁核和动脉发炎而加剧心脏病风险。而其他 公司试图现代化警报系统，他们未能解决压力的问题， 警报，因为他们专注于提醒“站”，而不是个别消防员。需要大力发展 为消防员提供了一个压力较小的警报系统。本SBIR I期R43研究的目的是 开发商业上可行的消防员警报系统（FFAS），由专有的可穿戴设备组成， 叫“床铺警报”的振动床集体“个人警报设备”，可穿戴设备和BunkAlerts 加强消防员的警报过程，用触觉警报代替刺耳的声音警报， 消防员的手腕这种替代方法旨在显著降低心动过速反应 与传统警报系统相关联。满足这一需求有可能减少消防员的ODD， 改善全世界1540万消防员的生活质量。EaseAlert的FFAS的可行性 在三（3）个州的六（6）个消防部门的现场测试中收集的初步数据加强了这一点 EaseAlert的原型FFAS（“Gen 1”）成功地向消防员发送了超过10，000个警报， 没有漏接电话的紧急情况我们的FFAS在降低压力和SCD风险方面的潜力 初步数据表明，消防员的这种说法得到了支持：1）噪音会引发惊吓反应，2）触觉 警报与正效价和高唤醒相关联。拟议的研究将完成与 两个目标：目标1 -开发商业上可行的FFAS，目标2 -确定FFAS在以下方面的有效性： 降低心脏反应性和改善睡眠。EaseAlert将利用Gen 1 FFAS作为基础， 开发目标1中概述的Gen 2 FFAS。目标2将在受试者内试验中测试两个研究假设 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将显著改善 睡眠效率。在第一阶段成功完成后，我们的Gen 2 FFAS和试点试验将证明 第二阶段的技术优点和可行性。II期将进行大型随机平行组临床试验 研究了这种创新的警报系统对生理和心理的影响， 皮质醇（应激）和C反应蛋白等重要生物标志物的长期结局 （炎症）除了睡眠结果和心理功能。