Clinical trial NCT01672502: Fire Fighter Fatigue Management Program: Operation Fight Fatigue
Official title: Fire Fighter Fatigue Management Program: Operation Fight Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shift-Work Sleep Disorder
Insomnia
Restless Leg Syndrome
Obstructive Sleep Apnea
Impaired Driving
Keywords: sleep
firefighter
fire
apnea
insomnia
shift
narcolepsy
restless leg
rls
fatigue
Optalert
actigraph
actigraphy
actiwatch
safety
sleepiness
sleepy
work
hours
FEMA
drowsy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Federal Emergency Management Agency
First posted: 2012-08-27
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Firefighters frequently work extended duration shifts and long work weeks which have adverse effects on alertness, health, safety and performance. This protocol uses a survey instrument to examine the effects of extended duration shifts on safety outcomes (e.g., motor vehicle crashes, accidents, injuries), health (e.g., diagnosis and treatment of sleep disorders, improved general health indices, decreased number of sick days), and performance (e.g., decreased response time). This study will expand understanding of the nature, scope, etiology and consequences of firefighter fatigue and increase our ability to develop guidelines that can be generalized across fire departments throughout North America. This study could provide an avenue to make lasting policy improvements that could enhance the safety, health, and performance of firefighters.

Detailed description: Firefighters work some of the most challenging schedules known under highly stressful and demanding conditions. The need to work frequent extended shifts leads to acute and chronic sleep deficiency as well as disruption of circadian rhythms. Firefighters on-call overnight are also particularly susceptible to sleep inertia, the neurocognitive impairment experienced immediately upon waking. In addition, it is likely that a significant proportion of firefighters suffer from undiagnosed sleep disorders, which further impair sleep and exacerbate fatigue.

The proposed fatigue countermeasure aims to increase sleep opportunities, and thereby improve firefighter safety and health. We will be conducting a station-level, randomized clinical trial of policies designed to maximize sleep opportunities during current 24-hour shifts to improve alertness, performance, health and safety in firefighters.

We will leverage the comprehensive fatigue management program we developed and the web-based technology we implemented in previous Federal Emergency Management Agency projects, and will continue to offer our web-based education program and sleep disorders screening. By conducting a collaborative study involving sleep medicine clinicians, sleep researchers, a consultant on alarms, together with the representatives from the management, and union leadership of the fire department, we expect we will develop a sleep optimization program with a high probability of success and test the hypotheses that increasing the sleep opportunity of firefighters will improve the alertness, performance, safety and physical and mental health of firefighters. The results of this study will provide policy makers with the scientific evidence they require to develop effective fatigue countermeasure programs for firefighters.

We will be conducting a randomized clinical trial, providing the most rigorous evaluation possible in an operational setting. Half the fire stations in a department will be randomly assigned to complete the intervention, termed Operation Fight Fatigue, in the first year of the study. The other half of the fire stations will complete the intervention in the second year. In this way, all firefighters will have the chance to benefit. We expect the fatigue countermeasure intervention to improve the alertness, performance, health and safety of firefighters. We will be evaluating a cost-effective intervention to improve the safety and health of firefighters in departments throughout the United States.

Eligibility criteria: Inclusion Criteria:

* Must be a fire department employee at a participating fire department.

Exclusion Criteria:

* May not be 17 years of age or younger.
* Will not be included if not a firefighter.

Primary outcomes:
measure: Sleep and health screening of firefighters using a composite of survey instruments
timeFrame: The baseline survey will be conducted at the start of the study and the follow-up survey will be conducted approximately 12 months later.
measure: Composite of firefighter information provided by the participating fire department
timeFrame: Up to 1 year
measure: Sleep and performance of firefighters measured by a composite of physiological monitoring
timeFrame: Participants will be involved for up to 3 weeks and will have a follow-up physical exam (including blood work) up to 1 year later.
Secondary outcomes:
measure: Documentation of motor vehicle crashes (MVC), and reported injuries
timeFrame: Up to 1 year
measure: Employment verification as a firefighter of all participants
timeFrame: Up to 1 year
measure: Composite of firefighter health information
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Division of Sleep Medicine; Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Charles Czeisler, PH.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: