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临床试验/NCT05641194
NCT05641194已完成不适用

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

Embry-Riddle Aeronautical University4 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2023年8月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
47
试验地点
4
主要终点
Sleep Efficiency

研究概览

简要总结

The purpose of this research is to test a commercially viable Fire Fighter Altering System (FFAS) comprised of proprietary wearables and optional bed shakers called BunkAlerts; collectively "personal alerting devices" as an alternative approach to the traditional fire alarm system used in fire stations. Participants (fire fighters) will be asked to take part in the study to investigate the impact of the new FFAS on cardiovascular response and sleep. This study includes three phases: 1) baseline, 2) implementation of EaseAlert FFAS with traditional alarm, and 3) implementation of EaseAlert FFAS without traditional alarm. Participants will be asked to wear an Actigraph wGT3x-BT and Polar H10 device to record sleep and heart rate data for 12 days at work in addition to EaseAlert FFAS device for 8 out of the 12 days at work. They will also be asked to complete a questionnaire and complete daily journal entries.

详细描述

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 of 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 the 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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must meet the following inclusion criteria:
  • Firefighters must be willing participants be over the age of 18 years
  • Have worked at their department for a minimum of two months (career department only) so that circadian rhythm is adjusted to the schedule
  • No extended absence or shift trading among the firefighters foreseen during the trial.
  • Nighttime call/run volume averaging at least one emergency call
  • Interest among the crew members to participate in the trial
  • Inclusion criteria for departments will include, but not be limited to:
  • Willingness to participate by department's chief and/or his/her designee
  • No past experience with the EaseAlert FFAS
  • Four or more firehouses/stations
  • Willingness to identify a departmental point of contact for collaboration with the research team
  • Interest among crews to test the new alert system.

排除标准

  • non firefighter

结局指标

主要结局

Sleep Efficiency

时间窗: Change from baseline to post interventions (6 days from baseline). Outcome will be assessed over 1 day per intervention.

Sleep Efficiency will be measures by wrist actigraphy (device: wGT3X-BT). Actilife 6.0 (issued by ActiGraph Co.) will be used to analyze actigraphy data. Sleep Efficiency is calculated by dividing (total sleep time by total time in bed) X 100. Change from baseline sleep efficiency to post interventions.

Heart Rate (mean)

时间窗: Change from baseline Heart Rate to post interventions (6 days from baseline). Outcome will be assessed over 1 day per intervention.

Heart Rate will be measured with Polar H10 Heart Rate Chest Strap Monitor connected via Bluetooth to wGT3X-BT Actigraphy device. Change from baseline Heart Rate to post interventions

Heart Rate (max)

时间窗: Change from baseline Heart Rate to post interventions (6 days from baseline). Outcome will be assessed over 1 day per intervention.

Heart Rate will be measured with Polar H10 Heart Rate Chest Strap Monitor connected via Bluetooth to wGT3X-BT Actigraphy device. Change from baseline Heart Rate to post interventions. Max HR will factor subjects' age.

次要结局

  • Satisfaction with EaseAlert during Day(Change from baseline day satisfaction to post interventions (6 days from baseline). Outcome will be assessed over 1 day per intervention.)
  • Pre-bed anxiety/stress(Change from baseline pre-bed anxiety/stress to post interventions (6 days from baseline). Outcome will be assessed over 1 day per intervention.)
  • Satisfaction with EaseAlert during Night(Change from baseline night satisfaction to post interventions (6 days from baseline). Outcome will be assessed over 1 day per intervention.)

研究者

发起方
Embry-Riddle Aeronautical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joel Billings, Ph.D.

Assistant Professor

Embry-Riddle Aeronautical University

研究点 (4)

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