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EaseAlert: Tactile Firefighter Alerting System

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ClinicalTrials.gov Identifier: NCT05641194
Recruitment Status : Recruiting
First Posted : December 7, 2022
Last Update Posted : September 8, 2023
Sponsor:
Collaborator:
National Development and Research Institutes, Inc.
Information provided by (Responsible Party):
Joel Billings, Ph.D., Embry-Riddle Aeronautical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Rate Sleep Habit Sleep Device: Legacy Alerting System Device: Intervention 2: EaseAlert and Legacy Alerting System Device: Intervention 3: EaseAlert Standalone Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
  1. Legacy Alerting System Description: Standard alerting system in place at the fire station.
  2. Intervention 2: EaseAlert and Legacy Alerting System Description: EaseAlert will activate five second before legacy alerting system activates through a tactile band worn by firefighters.
  3. Intervention 3: 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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: EaseAlert: Tactile Firefighter Alerting System Designed to Reduce Negative Cardiovascular Outcomes and Sleep Disturbances
Actual Study Start Date : August 26, 2023
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single arm - intervention Device: Legacy Alerting System
Description: Standard alerting system in place at the fire station.

Device: Intervention 2: EaseAlert and Legacy Alerting System
Description: EaseAlert will activate five second before legacy alerting system activates through a tactile band worn by firefighters.

Device: Intervention 3: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Heart Rate (mean) [ Time Frame: Change from baseline Heart Rate to first post interventions (6 days from baseline) and second post intervention (6 days from first post intervention). 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

  2. Heart Rate (max) [ Time Frame: Change from baseline Heart Rate to first post interventions (6 days from baseline) and second post intervention (6 days from first post intervention). 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.

  3. Sleep Efficiency [ Time Frame: Change from baseline sleep efficiency to first post interventions (6 days from baseline) and second post intervention (6 days from first post intervention). Outcome will be assessed over 1 night 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.


Secondary Outcome Measures :
  1. Sleepiness [ Time Frame: Change from baseline afternoon sleepiness to first post interventions (6 days from baseline) and second post intervention (6 days from first post intervention). Outcome will be assessed over 1 day per intervention. ]
    Sleepiness will be assessed at 1:00 pm on the assessment day using the Stanford Sleepiness Scale (7-point Likert scale: higher scores indicate worse outcome). Change from baseline afternoon sleepiness to post interventions.

  2. Satisfaction with EaseAlert during Night [ Time Frame: Change from baseline night satisfaction to first post interventions (6 days from baseline) and second post intervention (6 days from first post intervention). Outcome will be assessed over 1 day per intervention. ]
    Satisfaction with EaseAlert during the night will be assessed with a 10-point VAS Likert scale (lower scores indicate worse outcome) and an open ended option for additional thoughts. Change from baseline night satisfaction to post interventions.

  3. Satisfaction with EaseAlert during Day [ Time Frame: Change from baseline day satisfaction to first post interventions (6 days from baseline) and second post intervention (6 days from first post intervention). Outcome will be assessed over 1 day per intervention. ]
    Satisfaction with EaseAlert during the day will be assessed with a 10-point VAS Likert scale (lower scores indicate worse outcome) and an open ended option for additional thoughts. Change from baseline day satisfaction to post interventions.

  4. Pre-bed anxiety/stress [ Time Frame: Change from baseline pre-bed anxiety/stress to first post interventions (6 days from baseline) and second post intervention (6 days from first post intervention). Outcome will be assessed over 1 day per intervention. ]
    Pre-bed anxiety/stress will be assessed with a 10-point VAS Likert scale (higher scores indicate worse outcomes) prior to bed. Change from baseline pre-bed anxiety/stress to post interventions.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-

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.

Exclusion Criteria:

  • non firefighter
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05641194


Contacts
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Contact: Joel M Billings, Ph.D. 8005226787 joel.billings@erau.edu

Locations
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United States, Oklahoma
Stillwater Fire Department Recruiting
Stillwater, Oklahoma, United States, 74074
Contact: Joel Billings    800-522-6787    joel.billings@erau.edu   
Sponsors and Collaborators
Embry-Riddle Aeronautical University
National Development and Research Institutes, Inc.
Investigators
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Principal Investigator: Joel M Billings, Ph.D. Embry-Riddle Aeronautical University
More Information
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Responsible Party: Joel Billings, Ph.D., Assistant Professor, Embry-Riddle Aeronautical University
ClinicalTrials.gov Identifier: NCT05641194    
Other Study ID Numbers: 22-131
First Posted: December 7, 2022    Key Record Dates
Last Update Posted: September 8, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents