NCT01988129

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.'

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

March 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 29, 2015

Completed
Last Updated

March 16, 2017

Status Verified

February 1, 2017

Enrollment Period

4.5 years

First QC Date

July 27, 2010

Results QC Date

April 29, 2015

Last Update Submit

February 8, 2017

Conditions

Keywords

sleepfirefighterfireapneainsomniashiftnarcolepsyrestless legrlsfatigueactigraphactigraphyactiwatchsafetysleepinesssleepyworkhoursFederal Emergency Management Agencydrowsy

Outcome Measures

Primary Outcomes (4)

  • Firefighters' Health, as Determined by Number of 'Sick' Days Over 12 Months

    We assessed 'sick days' cumulatively over 12 months in two ways from departmental payroll records; the number of 24-hour pay periods coded as 'sick' time per firefighter and the number of 24-hr pay periods coded as injury and disability per firefighter. Fewer sick days is indicative of better health.

    12 months

  • Firefighter Safety, as Determined by Motor Vehicle Crashes Over 12 Months

    Fewer motor vehicle crashes is indicative of better health. We assessed motor vehicle crashes cumulatively over 12 months. Accidents were counted as any incident that resulted in the filing and review of a departmental Fleet Accident Report.

    12 months

  • Firefighter Safety, as Determined by On-the-job Injuries Over 12 Months

    Fewer on-the-job injuries is indicative of better health. We assessed injuries cumulatively over 12 months. Injuries that triggered the filing of an official city government accident report as the result of following normal departmental procedures were included in this study.

    12 months

  • Firefighters' Performance, as Determined by Response Time Over 12 Months

    A lower response time is indicative of better performance. Following detailed review of departmental procedures and records, we determined that 'turn-out time' was already very rapid and not considered an accurate measure of firefighters' performance by the department. Similarly, 'clearance time' (time from the start until the end of the event), which could last for many hours, was also not considered an appropriate measure of firefighter' performance in relation to sleep and alertness given the multiple factors, many of which are not under the control of the firefighters, that could affect clearance times. We therefore did not address this aim.

    12 months

Secondary Outcomes (7)

  • Change in the Mean Total Sleep Time

    Baseline to 12 months

  • Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleepy During Meetings

    Baseline to 12 months

  • Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping on the Telephone

    Baseline to 12 months

  • Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Driving

    Baseline to 12 months

  • Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Stopped in Traffic

    Baseline to 12 months

  • +2 more secondary outcomes

Other Outcomes (1)

  • Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire

    Baseline (Study start)

Study Arms (2)

Intervention

EXPERIMENTAL

Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening. The 32 fire department stations were paired according to the previous calendar years' workload. One station from each pair was randomly assigned to receive the intervention program. Sleep education sessions were scheduled according to station. On the education day(s) assigned to that stations, all personnel present that day were instructed to attend, and 542/601 did so.

Other: Sleep disorders education and screening

Control

NO INTERVENTION

Current practice. Firefighters in the Control Stations continued their normal role and were not invited to attend the sleep education and sleep disorders screening program. There was no formal contact with the control group. As part of normal operational requirements, a small number of firefighters are reassigned to other stations each day and therefore 18/588 firefighters from control stations happened to be reassigned to an intervention station on the day of the education session and attended the session.

Interventions

Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up.

Intervention

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Non fire department employees

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BWH Division of Sleep Medicine

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

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

Interventions

Mass Screening

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Results Point of Contact

Title
Steven W. Lockley PhD
Organization
Brigham and Women's Hospital

Study Officials

  • Steven Lockley, Ph.D.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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 A Czeisler, Ph.D., M.D.,

Study Record Dates

First Submitted

July 27, 2010

First Posted

November 20, 2013

Study Start

March 1, 2009

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 16, 2017

Results First Posted

July 29, 2015

Record last verified: 2017-02

Locations