AzTrials
AzTrials

Workplace StressNCT05659277

The Effects of Stress & Irregular Shift Hours on First Responders

An observational study of Workplace Stress and Mental Health, run by Endominance at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Workplace Stress, Mental Health, HRV
What is being tested?
Workplace Stress and Irregular shift hours
How many people
500 participants
Where
1 siteUnited States
Study dates
12 Oct 2022to 1 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: First Responders including firefighters, police, SWAT, EMTs, detectives, and dispatchers.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Endominance Inc.

    Irvine, California, 92618

Other trials in United States

About this study

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

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:

Read more
  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.

Read the detailed description

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
Being tested
Workplace Stress and Irregular shift hours
Keywords
First Responder, Shift Work, PHQ9, GAD7
Medical subject headings
Occupational Stress, Psychological Well-Being, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Workplace Stress and Irregular shift hoursOther

    The physiological, psychological, and cognitive impacts that workplace stress and irregular shift hours have on first responders.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: up to 3 months

  2. Brain Functionality via Electroencephalogram (EEG)

    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.

    Measured: up to 3 months

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

    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.

    Measured: up to 3 months

Secondary outcomes (1)

  1. Cognitive Orientation & Social-Emotional Competency Assessment (COSEC)

    An online cognitive propensity and behavioral preference diagnostic tool. COSEC is designed to understand people's various tendencies that occur during the process between perceiving the environment and responding in action. It illustrates an individual's personality and aptitude as an outcome shaped by their environment and the perception of the world around them. COSEC incorporates the environmental impact on the individual by looking at the unique process of a person's perception, conception, and behavior process. Assessments are scored using an algorithm to generate quantified measurements based on multifactorial relationships between a subject's responses.

    Participants who complete the study will receive their personalized digital report called the COBI report.

    Measured: up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2022
  2. Study start12 Oct 2022
  3. Primary completion11 Apr 2023 (estimated)
  4. Study completion1 May 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05659277
Sponsor's protocol ID
10433
Status last verified
Dec 2022
First submitted
7 Nov 2022
Last updated
22 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Workplace Stress and Mental Health, run by Endominance at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

aMCI (Amnestic Mild Cognitive Impairment) via Electroencephalogram (EEG) (time frame: up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05659277.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in