NCT05659277

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2022

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

December 22, 2022

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

November 7, 2022

Last Update Submit

December 20, 2022

Conditions

Keywords

First ResponderShift WorkPHQ9GAD7

Outcome Measures

Primary Outcomes (3)

  • 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.

    up to 3 months

  • 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.

    up to 3 months

  • 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.

    up to 3 months

Secondary Outcomes (1)

  • Cognitive Orientation & Social-Emotional Competency Assessment (COSEC)

    up to 3 months

Other Outcomes (5)

  • Microbiome Analysis

    up to 3 months

  • Health and Lifestyle survey

    up to 3 months

  • Depression Scores - Patient Health Questionnaire (PHQ-9)

    up to 3 months

  • +2 more other outcomes

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endominance Inc.

Irvine, California, 92618, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples will be lab processed and analyzed for the diversity of gut bacteria, dietary habits as well as gut microbiota-derived metabolites from exogenous dietary substrates and endogenous host compounds. Individual results will not be provided.

MeSH Terms

Conditions

Occupational StressPsychological Well-BeingStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehaviorPersonal SatisfactionStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2022

First Posted

December 21, 2022

Study Start

October 12, 2022

Primary Completion

April 11, 2023

Study Completion

May 1, 2023

Last Updated

December 22, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations