NCT05641194

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

October 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

August 26, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

October 28, 2022

Last Update Submit

March 11, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Heart Rate (mean)

    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

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

  • Heart Rate (max)

    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.

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

  • Sleep Efficiency

    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.

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

Secondary Outcomes (3)

  • 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.

  • 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.

Study Arms (1)

Single arm - intervention

EXPERIMENTAL
Device: Legacy Alerting SystemDevice: Intervention 2: EaseAlert Standalone

Interventions

Description: Standard alerting system in place at the fire station.

Single arm - intervention

Description: EaseAlert will activate and alert the subject of an emergency call without the legacy alerting system. EaseAlert (standalone) replaces the legacy alerting system.

Single arm - intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • non firefighter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Jackson County Fire District

Blue Springs, Missouri, 64015, United States

Location

Stillwater Fire Department

Stillwater, Oklahoma, 74074, United States

Location

Study Officials

  • Joel M Billings, Ph.D.

    Embry-Riddle Aeronautical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 1. Legacy Alerting System Description: Standard alerting system in place at the fire station. 2. Intervention 2: EaseAlert Standalone Description: EaseAlert will activate and alert the subject of an emergency call without the legacy alerting system. EaseAlert (standalone) replaces the legacy alerting system.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 28, 2022

First Posted

December 7, 2022

Study Start

August 26, 2023

Primary Completion

October 1, 2024

Study Completion

January 31, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations