Shift-Work Sleep DisorderNCT01988129
Fire Fighter Fatigue Management Program: Operation Healthy Sleep
A study testing Sleep disorders education and screening in people with Shift-Work Sleep Disorder and Insomnia, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shift-Work Sleep Disorder, Insomnia, Restless Leg Syndrome
- What is being tested?
- Sleep disorders education and screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,189 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Non fire department employees
Trial locations and contacts
1 site in 1 country.
United States1 site
BWH Division of Sleep Medicine
Boston, Massachusetts, 02215
About this study
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.'
Read the 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:
- improve the mean total sleep, alertness and cognitive performance of firefighters;
- improve firefighter safety, as determined by:
- decreased rates of motor vehicle crashes;
- decreased on-the-job injuries;
- improve firefighter performance, as determined by decreased response time;
- improve firefighters' health, as determined by:
- diagnosis and treatment of sleep disorders
- improved general health indices
- decreased number of 'sick' days
- improve firefighters' and families' job satisfaction and ability to cope with extended work hours.
- Conditions
- Shift-Work Sleep Disorder, Insomnia, Restless Leg Syndrome, Obstructive Sleep Apnea, Impaired Driving, Injuries
- Being tested
- Sleep disorders education and screening
- 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
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Sleep Initiation and Maintenance Disorders, Restless Legs Syndrome, Sleep Apnea, Obstructive, Wounds and Injuries, Apnea, Narcolepsy, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep disorders education and screeningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (7)
Change in the Mean Total Sleep Time
A higher total sleep time is indicative of better sleep. The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.
The analysis for total sleep time is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey, and had at least 1 week of work scheduled in the 4 weeks prior to each survey.
Measured: Baseline to 12 months
Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleepy During Meetings
A lower number of times reported falling asleep during meetings is indicative of better alertness and cognitive performance.
The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.
The analysis for the number of times individuals reported sleeping during meetings is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey.
Measured: Baseline to 12 months
Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping on the Telephone
A lower number of times reported sleeping on the telephone is indicative of better alertness and cognitive performance.
The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.
The analysis for the number of times individuals reported sleeping on the telephone is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey.
Measured: Baseline to 12 months
Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Driving
A lower number of times reported sleeping while driving is indicative of better alertness and cognitive performance.
The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.
The analysis for the number of times individuals reported being sleepy while driving is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey.
Measured: Baseline to 12 months
Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Stopped in Traffic
A lower number of times reported sleeping while stopped in traffic is indicative of better alertness and cognitive performance.
The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.
The analysis for the number of times individuals reported sleeping while stopped in traffic is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey.
Measured: Baseline to 12 months
Change in Firefighters' Health, as Determined by General Health Indices;
The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.
A higher health index is indicative of better health. We assessed general health with the question ' In general, would you say your health is Excellent/Very good/Good/Fair/Poor?' and coded the answers from 5-1, respectively.
Measured: Baseline to 12 months
Change Firefighters' and Families' Job Satisfaction and Ability to Cope With Extended Work Hours
In developing the study detail with the department, it became apparent that it would be impractical to assess firefighters' and families' job satisfaction and ability to cope with extended work hours in a meaningful way. We therefore did not address this aim.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startMar 2009
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shift-Work Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Emergency Management Agency
- Responsible party
- Principal investigator, Charles Andrew Czeisler, MD, PhD, Brigham and Women's Hospital
- Investigators
- Steven Lockley, Ph.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988129
- Sponsor's protocol ID
- 2009-P-000697
- Status last verified
- Feb 2017
- First submitted
- 27 Jul 2010
- Last updated
- 16 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fire Fighter Fatigue Management Program: Operation Healthy Sleep
- ClinicalTrials.gov ID
- NCT01988129
- Acronym / sponsor ID
- 2009-P-000697
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,189 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Federal Emergency Management Agency
- Study start
- Mar 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Posted 29 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- improve the mean total sleep, alertness and cognitive performance of firefighters;
- improve firefighter safety, as determined by:
- decreased rates of motor vehicle crashes;
- decreased on-the-job injuries;
- improve firefighter performance, as determined by decreased response time;
- improve firefighters' health, as determined by:
- diagnosis and treatment of sleep disorders
- improved general health indices
- decreased number of 'sick' days
- improve firefighters' and families' job satisfaction and ability to cope with extended work hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Sleep disorders education and screeningWorkplace-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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Non fire department employees
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep disorders education and screeningFirefighters 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. | Other | Intervention |
Primary outcome
Firefighters' Health, as Determined by Number of 'Sick' Days Over 12 Months
Time frame: 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.
Firefighter Safety, as Determined by Motor Vehicle Crashes Over 12 Months
Time frame: 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.
Firefighter Safety, as Determined by On-the-job Injuries Over 12 Months
Time frame: 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.
Firefighters' Performance, as Determined by Response Time Over 12 Months
Time frame: 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.
7 secondary outcomes
Change in the Mean Total Sleep Time
Time frame: Baseline to 12 months
Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleepy During Meetings
Time frame: Baseline to 12 months
Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping on the Telephone
Time frame: Baseline to 12 months
Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Driving
Time frame: Baseline to 12 months
Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Stopped in Traffic
Time frame: Baseline to 12 months
Change in Firefighters' Health, as Determined by General Health Indices;
Time frame: Baseline to 12 months
Change Firefighters' and Families' Job Satisfaction and Ability to Cope With Extended Work Hours
Time frame: Baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Lockley, Ph.D. principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep disorders education and screening in people with Shift-Work Sleep Disorder and Insomnia, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Firefighters' Health, as Determined by Number of 'Sick' Days Over 12 Months (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.