Clinical trial NCT01988129: Fire Fighter Fatigue Management Program: Operation Healthy Sleep
Official title: Fire Fighter Fatigue Management Program: Operation Healthy Sleep
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shift-Work Sleep Disorder
Insomnia
Restless Leg Syndrome
Obstructive Sleep Apnea
Impaired Driving
Injuries
Keywords: sleep
firefighter
fire
apnea
insomnia
shift
narcolepsy
restless leg
rls
fatigue
actigraph
actigraphy
actiwatch
safety
sleepiness
sleepy
work
hours
Federal Emergency Management Agency
drowsy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Federal Emergency Management Agency
First posted: 2013-11-20
Enrollment: 1189
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 work some of the most demanding schedules known under highly stressful and demanding conditions. The need to work frequent extended shifts and long work weeks leads to acute and chronic partial sleep deprivation as well as misalignment of circadian phase. Sleep disorders are common, costly, and treatable, but often remain undiagnosed and untreated and it is likely that a significant proportion of firefighters suffer from undiagnosed sleep disorders which will further impair their sleep and exacerbate fatigue.In the current proposal, we aim to address the health, performance and safety issues related to fatigue in firefighters and test the effectiveness of a Comprehensive Firefighter Fatigue Management Program (CFFMP) that we have termed 'Operation Healthy Sleep.'

Detailed description: We propose to use a station-level, randomized experimental design to test the hypotheses that implementation of a Comprehensive Firefighter Fatigue Management Program will:

1. improve the mean total sleep, alertness and cognitive performance of firefighters;
2. improve firefighter safety, as determined by:

   1. decreased rates of motor vehicle crashes;
   2. decreased on-the-job injuries;
3. improve firefighter performance, as determined by decreased response time;
4. improve firefighters' health, as determined by:

   1. diagnosis and treatment of sleep disorders
   2. improved general health indices
   3. decreased number of 'sick' days
5. improve firefighters' and families' job satisfaction and ability to cope with extended work hours.

Eligibility criteria: Inclusion Criteria:

* This proposal includes research involving human subjects (fire department employees).
* Active firefighters working in the study fire department will be eligible to participate in the study.
* All applicants will be considered without bias, regardless of race, ethnicity, or national origin.

Exclusion Criteria:

* Non fire department employees

Primary outcomes:
measure: Firefighters' Health, as Determined by Number of 'Sick' Days Over 12 Months
timeFrame: 12 months
measure: Firefighter Safety, as Determined by Motor Vehicle Crashes Over 12 Months
timeFrame: 12 months
measure: Firefighter Safety, as Determined by On-the-job Injuries Over 12 Months
timeFrame: 12 months
measure: Firefighters' Performance, as Determined by Response Time Over 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Change in the Mean Total Sleep Time
timeFrame: Baseline to 12 months
measure: Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleepy During Meetings
timeFrame: Baseline to 12 months
measure: Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping on the Telephone
timeFrame: Baseline to 12 months
measure: Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Driving
timeFrame: Baseline to 12 months
measure: Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Stopped in Traffic
timeFrame: Baseline to 12 months
measure: Change in Firefighters' Health, as Determined by General Health Indices;
timeFrame: Baseline to 12 months
measure: Change Firefighters' and Families' Job Satisfaction and Ability to Cope With Extended Work Hours
timeFrame: Baseline to 12 months
Other outcomes:
measure: Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire
timeFrame: Baseline (Study start)
Locations:
city: Boston
country: United States
facility: BWH Division of Sleep Medicine
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Steven Lockley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: