NCT01672502

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
620

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 27, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

1.7 years

First QC Date

August 16, 2012

Last Update Submit

March 15, 2016

Conditions

Keywords

sleepfirefighterfireapneainsomniashiftnarcolepsyrestless legrlsfatigueOptalertactigraphactigraphyactiwatchsafetysleepinesssleepyworkhoursFEMAdrowsy

Outcome Measures

Primary Outcomes (3)

  • Sleep and health screening of firefighters using a composite of survey instruments

    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.

    The baseline survey will be conducted at the start of the study and the follow-up survey will be conducted approximately 12 months later.

  • Composite of firefighter information provided by the participating fire department

    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.

    Up to 1 year

  • Sleep and performance of firefighters measured by a composite of physiological monitoring

    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.

    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 (3)

  • Documentation of motor vehicle crashes (MVC), and reported injuries

    Up to 1 year

  • Employment verification as a firefighter of all participants

    Up to 1 year

  • Composite of firefighter health information

    Up to 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

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 programOther: Sleep disorder detection and treatmentOther: Optimization of Sleep in Fire Station

Control

ACTIVE COMPARATOR

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 programOther: Sleep disorder detection and treatment

Interventions

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.

Also known as: Operation Fight Fatigue, OFF, Comprehensive Fatigue Management Training Program
ControlIntervention

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.

Also known as: Operation Fight Fatigue, OFF, Comprehensive Fatigue Management Training Program
ControlIntervention

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.

Also known as: Operation Fight Fatigue, OFF, Comprehensive Fatigue Management Training Program
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Sleep Medicine; Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian RhythmSleep Initiation and Maintenance DisordersRestless Legs SyndromeSleep Apnea, ObstructiveApneaNarcolepsyFatigueSleepiness

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental DisordersSleep Disorders, IntrinsicParasomniasSleep Apnea SyndromesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsDisorders of Excessive Somnolence

Study Officials

  • Charles Czeisler, PH.D., M.D.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Charles Andrew Czeisler, MD, PhD

Study Record Dates

First Submitted

August 16, 2012

First Posted

August 27, 2012

Study Start

September 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

March 17, 2016

Record last verified: 2016-03

Locations