Heart RateNCT05641194
EaseAlert: Tactile Firefighter Alerting System
A study testing Legacy Alerting System and Intervention 2: EaseAlert Standalone in people with Heart Rate and Sleep Habit, run by Embry-Riddle Aeronautical University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Rate, Sleep Habit, Sleep
- What is being tested?
- Legacy Alerting System and Intervention 2: EaseAlert Standalone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Aug 2023to 31 Jan 2025
- Phase
- Interventional
- 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
Who may be able to join
- -
- 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
Show all 13Show fewer
- 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.
Who cannot join
- non firefighter
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Central Jackson County Fire District
Blue Springs, Missouri, 64015
Stillwater Fire Department
Stillwater, Oklahoma, 74074
About this study
Official title: EaseAlert: Tactile Firefighter Alerting System Designed to Reduce Negative Cardiovascular Outcomes and Sleep Disturbances
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.
Read the 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.
- Conditions
- Heart Rate, Sleep Habit, Sleep
- Being tested
- Legacy Alerting System, Intervention 2: EaseAlert Standalone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Legacy Alerting SystemDevice
Description: Standard alerting system in place at the fire station.
Intervention 2: EaseAlert StandaloneDevice
Description: EaseAlert will activate and alert the subject of an emergency call without the legacy alerting system. EaseAlert (standalone) replaces the legacy alerting system.
| Study group | Role | What they receive |
|---|---|---|
| Single arm - intervention | Experimental | Not described Receives: Device: Legacy Alerting System; Device: Intervention 2: EaseAlert Standalone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Change from baseline pre-bed anxiety/stress to post interventions (6 days from baseline). Outcome will be assessed over 1 day per intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start26 Aug 2023
- Primary completion1 Oct 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Embry-Riddle Aeronautical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Development and Research Institutes, Inc.
- Responsible party
- Principal investigator, Joel Billings, Ph.D., Embry-Riddle Aeronautical University
- Investigators
- Joel M Billings, Ph.D., Principal investigator, Embry-Riddle Aeronautical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641194
- Sponsor's protocol ID
- 22-131
- Status last verified
- Mar 2025
- First submitted
- 28 Oct 2022
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EaseAlert: Tactile Firefighter Alerting System Designed to Reduce Negative Cardiovascular Outcomes and Sleep Disturbances
- ClinicalTrials.gov ID
- NCT05641194
- Acronym / sponsor ID
- 22-131
- Conditions
- Heart Rate, Sleep Habit, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Embry-Riddle Aeronautical UniversityUniversity, hospital or other
- Collaborators
- National Development and Research Institutes, Inc.
- Study start
- 26 Aug 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single arm - intervention | Experimental | Device: Legacy Alerting System, Device: Intervention 2: EaseAlert Standalone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- -
- 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
Key exclusion criteria (1 listed)
- non firefighter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Legacy Alerting SystemDescription: Standard alerting system in place at the fire station. | Device | Single arm - intervention |
| Intervention 2: EaseAlert StandaloneDescription: EaseAlert will activate and alert the subject of an emergency call without the legacy alerting system. EaseAlert (standalone) replaces the legacy alerting system. | Device | Single arm - intervention |
Primary outcome
Heart Rate (mean)
Time frame: Change from baseline Heart Rate to post interventions (6 days from baseline). 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
Heart Rate (max)
Time frame: Change from baseline Heart Rate to post interventions (6 days from baseline). 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.
Sleep Efficiency
Time frame: Change from baseline to post interventions (6 days from baseline). Outcome will be assessed over 1 day 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.
3 secondary outcomes
Satisfaction with EaseAlert during Night
Time frame: 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
Time frame: 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
Time frame: Change from baseline pre-bed anxiety/stress to post interventions (6 days from baseline). Outcome will be assessed over 1 day per intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Heart Rate
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Not yet recruiting
Boyle-Davis Mouth Gag Timing in Pediatric Tonsil Surgery
Tonsillectomy and Adenotonsillectomy in Children
RecruitingObservational study
Clinical Performance and Usability of the Heart Rate and Impedance Respiration Monitor Cable
Monitoring, ECG
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Not yet recruiting
Feasibility Pilot of Remote Mindfulness Training Across Multiple Sites (REFORM Pilot)
Psychological Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel M Billings, Ph.D. principal investigator
Embry-Riddle Aeronautical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Legacy Alerting System and Intervention 2: EaseAlert Standalone in people with Heart Rate and Sleep Habit, run by Embry-Riddle Aeronautical University at 2 sites 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 13 inclusion and 1 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: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heart Rate (mean) (time frame: Change from baseline Heart Rate to post interventions (6 days from baseline). Outcome will be assessed over 1 day per intervention.). 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?
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 13 Mar 2025.