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临床试验/NCT05659277
NCT05659277Enrolling By Invitation不适用

The Physiological, Psychological, and Cognitive Effects of Workplace Stress, SelfManagement Habits, and Irregular Shift Hours on First Responders

Endominance1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年10月12日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
500
试验地点
1
主要终点
aMCI (Amnestic Mild Cognitive Impairment) via Electroencephalogram (EEG)

研究概览

简要总结

First Responders are expected to maintain high-performance levels under extreme conditions. However, constant intense workplace stress, physical work demands, and irregular shift hours are taking a severe toll on frontline workers. These demands often lead to physical and mental health problems, poor job performance, and lifestyle issues. Without better support and resources, these demands will continue to cause first responders to be trapped in a vicious cycle that typically includes occupational trauma, stress, and maladaptive coping skills.

The purpose of this research is to:

  1. Better understand the physiological, psychological, and cognitive impacts workplace stress and irregular shift hours have on first responders
  2. Better understand the most prominent challenges first responders face when trying to manage their own physical and mental health.

Through the results of this study, we hope to identify possible solutions/interventions at the individual, clinical and departmental levels to help first responders better manage their stress and improve their quality of life.

详细描述

This study aims to expand and improve current research regarding the physiological, psychological, and cognitive impacts that workplace stress and irregular shift hours have on first responders. The investigators will examine electroencephalogram (EEG)/heart rate variability (HRV) measurements and gut microbiota to help bridge the connection between the impacts of a physically and mentally demanding workplace with highly irregular shift hours on first responders. There are numerous studies conducted to evaluate how stress impacts first responders in areas such as physical and mental health, but there lacks comprehensive research that examines the physiological, psychological, and cognitive impacts of workplace stress and irregular shift hours have on first responders in the U.S.

There also lacks information of the challenges first responders face when trying to manage their physical and mental health. To conduct these objectives, we will focus on these specific aspects:

  1. The impact of shift hours (especially longer shift hours, e.g., firefighters 24 vs. 48 shift hours) on first responders, specifically in connection to sleep disorders and other cognitive function-related issues.
  2. The connection between workplace incidents and stress/alertness levels - even during off-duty hours.
  3. First responder self-help/stress relief coping techniques or modalities and their efficacy

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Full-Time, actively employed First Responder
  • Participants must be 18 years of age and older
  • Participants must be able to read and write English
  • Participants must be able to provide consent independently
  • Participants must provide a legitimate postal address/P.O Box
  • Participants must have access to a device such as a computer or a smartphone

排除标准

  • Unable to provide a stool sample due to health status or functional impairment
  • Unable to complete EEG measurement due to health status
  • Cognitively impaired persons
  • Department volunteers
  • Prisoners

结局指标

主要结局

aMCI (Amnestic Mild Cognitive Impairment) via Electroencephalogram (EEG)

时间窗: up to 3 months

Using an advanced wireless EEG device, PPG is measured using the following frequency bands for the prediction of aMCI: Absolute power of delta(1-4Hz), alpha1(8-10Hz), beta2(15-20Hz), beta3(20-30Hz), gamma(30-45Hz) and relative power-delta (1-4Hz), theta (4-8Hz), alpha1 (8-10Hz), alpha2 (10-12Hz), beta1 (10-15Hz), beta2(15-20Hz) and gamma(30-45Hz). Specially trained machine learning algorithms can process quantitative EEG to identify subtle evidence of aMCI, thus enabling early interventions that have the greatest potential for delaying or preventing the progression of aMCI to Alzheimer's disease. Individual results will be provided.

Brain Functionality via Electroencephalogram (EEG)

时间窗: up to 3 months

PPG is measured using the following frequency bands for the prediction of brain functionality: Absolute power of delta(1-4Hz), alpha1(8-10Hz), beta2(15-20Hz), beta3(20-30Hz), gamma(30-45Hz) and relative power-delta (1-4Hz), theta (4-8Hz), alpha1 (8-10Hz), alpha2 (10-12Hz), beta1 (10-15Hz), beta2(15-20Hz) and gamma(30-45Hz). 3D brainwave analysis highlights the functional, rather than the structural, status of key brain areas, offering special insights into cortical dysfunction or compensatory activity. This brain map highlights areas where the balance between slow (theta, 4-8Hz) waves and fast (beta, 15-20Hz) waves differs from that expected based on age and sex-matched normal healthy population. Lower-than-expected levels of function are reported along with higher- than expected levels. Individual results will be provided.

ANS (Autonomic Nervous System) stress analysis via simultaneous Electroencephalogram (EEG) and HRV (heart rate variability)

时间窗: up to 3 months

The stress report analyzes ones PPG rhythm pattern with an AI algorithm, displaying 5 stages of stress from homeostasis to burnout (homeostasis, alarm, resistance, exhaustion, and burnout). HRV indicates balance between the activity of the two branches of the ANS. Individual results will be provided.

次要结局

  • Cognitive Orientation & Social-Emotional Competency Assessment (COSEC)(up to 3 months)

研究者

发起方
Endominance
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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