Trial record 11 of 77 for:    Open Studies | "Sleep Initiation and Maintenance Disorders"

Fire Fighter Fatigue Management Program: Operation Fight Fatigue

This study is currently recruiting participants.
Verified August 2013 by Brigham and Women's Hospital
Sponsor:
Collaborator:
Federal Emergency Management Agency
Information provided by (Responsible Party):
Charles Andrew Czeisler, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01672502
First received: August 16, 2012
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Shift-Work Sleep Disorder
Insomnia
Restless Leg Syndrome
Obstructive Sleep Apnea
Impaired Driving
Behavioral: Sleep health education provided via a web-based program
Other: Sleep disorder detection and treatment
Other: Optimization of Sleep in Fire Station

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fire Fighter Fatigue Management Program: Operation Fight Fatigue

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Sleep and health screening of firefighters using a composite of survey instruments [ Time Frame: The baseline survey will be conducted at the start of the study and the follow-up survey will be conducted approximately 12 months later. ] [ Designated as safety issue: Yes ]
    All firefighters in intervention and control stations will be asked to complete two surveys in which they document their work hours, sleep hours, sleep quality, caffeine consumption, and baseline health; their mood, sleepiness, and quality of life on a series of validated scales. Descriptions of any motor vehicle crashes, near miss crashes, and on-the-job injuries will also be obtained. Mental health will be assessed with three validated survey instruments. They will also receive the sleep disorders screening survey. Those found at high risk will be contacted to make aware.

  • Composite of firefighter information provided by the participating fire department [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    The following outcomes will be collected: a) work hours data: scheduled work hours, overtime and vacation time; b) health and safety data: driving accidents and vehicle damage (including severity of accidents in terms of financial cost, time away from work, and extent of injury), on-the-job injuries (related and unrelated to motor vehicle crashes), sick time; and c) job performance data: response time and clear time (i.e., time to initial response and completion of a self-initiated or assigned task) and other measures considered pertinent to firefighters' performance by the department.

  • Sleep and performance of firefighters measured by a composite of physiological monitoring [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Participants will participate in physiological monitoring to obtain objective data on sleep and performance. These data may also be used to validate the data reported on the survey. These firefighters will complete daily sleep/work diaries, wear an actigraph continuously and wear the Optalert glasses on the commute from each work shift. Subjects will also have 2 physical exams which include blood work.


Secondary Outcome Measures:
  • Documentation of motor vehicle crashes (MVC), and reported injuries [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    If a participant reports a motor vehicle crash, or an occupational injury, he or she will be asked to describe the incident in detail, and provide copies of police records, automobile repair receipts, or insurance records for documentation.

  • Employment verification as a firefighter of all participants [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    For the purposes of validating the study cohort approximately 10% may be randomly chosen to have their place of employment verified to ensure they are fire department employees. To do this our research staff will call, email, and/or send letters to the subject's place of employment asking to verify the status of the participant as either a past or present employee.

  • Composite of firefighter health information [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    First, we request access to the accident and injury reports from the department-wide measures to look at overall changes in health and safety between the groups. Second, we will ask subjects to provide a written medical release to allow the researchers to gain access to the work physicals. Third, if a subject is found to be at high risk for a sleep disorder and takes a sleep clinic referral, we will ask them to provide a written medical release to allow access to their sleep clinic information. Fourth, we would request access to occupational health records.


Estimated Enrollment: 6000
Study Start Date: September 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Firefighters in this group will receive at the beginning of the study an introduction to the study, sleep education, sleep disorder screening survey, health survey, increased sleep opportunities at their fire department, followed later by physiological monitoring of a portion of the firefighters, and then finally an 'end of year' survey at the end of the study.
Behavioral: Sleep health education provided via a web-based program
All firefighters in the experimental group and controls will be asked to complete an approximately 30 minute education session. This education session will split into two modules, module 1: an introduction to the program along with basic sleeps hygiene information and module 2: standard training. Topics covered in module 2 will include basic sleep physiology, the causes and consequences of sleep disorders, and fatigue countermeasures. We will emphasize strategies to maximize sleep and reduce fatigue both on and off work.
Other Names:
  • Operation Fight Fatigue
  • OFF
  • Comprehensive Fatigue Management Training Program
Other: Sleep disorder detection and treatment
Firefighters in the intervention districts will complete a sleep disorders screening questionnaire. The questionnaire will focus on identifying individuals who show increased likelihood of suffering from obstructive sleep apnea, insomnia, shift work disorder, and restless legs syndrome using validated screening tools. Those assessed to be at high risk for one of these sleep disorders will be referred to a local AASM-accredited Clinical Sleep Disorders Service for evaluation and, if necessary, treatment. Diagnosis and treatment of sleep-related disorders will reduce the risk of fatigue-related accidents and improve the health and safety of affected individuals.
Other Names:
  • Operation Fight Fatigue
  • OFF
  • Comprehensive Fatigue Management Training Program
Other: Optimization of Sleep in Fire Station
First, we will review and retrofit the sleeping quarters to provide a better environment for napping and sleep; light, noise, bed type, space, temperature, and location would all be considered and where possible, changes made to improve the sleeping environment. Secondly, we will work with management and union personnel to develop a 'sleep friendly' policy during the daytime, with specified protected times for naps during the day before the overnight work in order to reduce sleepiness during overnight work. Finally, we will upgrade the alerting systems, that is, we will work with management and union personnel to consider changing the policy that requires the sleeping areas of all stations to receive all alarm calls, even if that particular station is not required to attend the alarm.
Other Names:
  • Operation Fight Fatigue
  • OFF
  • Comprehensive Fatigue Management Training Program
Active Comparator: Control
Firefighters in this group will only receive an introduction to the study and a health survey, followed later by physiological monitoring of a portion of the firefighters, and then at the end of the study will receive the sleep disorders screening survey, sleep education (Intervention group received screening survey and education much earlier at the beginning of the study), and an 'end of year' survey. None of these firefighters will receive the increased sleep opportunities as the Intervention group will.
Behavioral: Sleep health education provided via a web-based program
All firefighters in the experimental group and controls will be asked to complete an approximately 30 minute education session. This education session will split into two modules, module 1: an introduction to the program along with basic sleeps hygiene information and module 2: standard training. Topics covered in module 2 will include basic sleep physiology, the causes and consequences of sleep disorders, and fatigue countermeasures. We will emphasize strategies to maximize sleep and reduce fatigue both on and off work.
Other Names:
  • Operation Fight Fatigue
  • OFF
  • Comprehensive Fatigue Management Training Program
Other: Sleep disorder detection and treatment
Firefighters in the intervention districts will complete a sleep disorders screening questionnaire. The questionnaire will focus on identifying individuals who show increased likelihood of suffering from obstructive sleep apnea, insomnia, shift work disorder, and restless legs syndrome using validated screening tools. Those assessed to be at high risk for one of these sleep disorders will be referred to a local AASM-accredited Clinical Sleep Disorders Service for evaluation and, if necessary, treatment. Diagnosis and treatment of sleep-related disorders will reduce the risk of fatigue-related accidents and improve the health and safety of affected individuals.
Other Names:
  • Operation Fight Fatigue
  • OFF
  • Comprehensive Fatigue Management Training Program

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 FEMA 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672502

Contacts
Contact: Conor S O'Brien, B.S. 617-525-2614 cobrien@rics.bwh.harvard.edu
Contact: Michael B Shreeve, B.A. 617-525-2622 mshreeve@partners.org

Locations
United States, Massachusetts
Division of Sleep Medicine; Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Michael B Shreeve    617-525-2617    mshreeve@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Federal Emergency Management Agency
Investigators
Principal Investigator: Charles Czeisler, PH.D., M.D. Brigham and Women's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Charles Andrew Czeisler, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01672502     History of Changes
Other Study ID Numbers: EMW-2010-FP-00521
Study First Received: August 16, 2012
Last Updated: August 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
sleep
firefighter
fire
apnea
insomnia
shift
narcolepsy
restless leg
rls
fatigue
Optalert
actigraph
actigraphy
actiwatch
safety
sleepiness
sleepy
work
hours
FEMA
drowsy

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Apnea
Fatigue
Restless Legs Syndrome
Sleep Apnea Syndromes
Sleep Disorders
Parasomnias
Psychomotor Agitation
Sleep Apnea, Obstructive
Sleep Disorders, Circadian Rhythm
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Dyskinesias
Psychomotor Disorders
Neurobehavioral Manifestations
Chronobiology Disorders
Occupational Diseases

ClinicalTrials.gov processed this record on April 23, 2014