Shift-Work Sleep DisorderNCT01672502
Fire Fighter Fatigue Management Program: Operation Fight Fatigue
A study testing Sleep health education provided via a web-based program, Sleep disorder detection and treatment and Optimization of Sleep in Fire Station 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 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… 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 health education provided via a web-based program, Sleep disorder detection and treatment and Optimization of Sleep in Fire Station
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Must be a fire department employee at a participating fire department.
Who cannot join
- May not be 17 years of age or younger.
- Will not be included if not a firefighter.
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Sleep Medicine; Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
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.
Read the 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 Federal Emergency Management Agency 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.
- Conditions
- Shift-Work Sleep Disorder, Insomnia, Restless Leg Syndrome, Obstructive Sleep Apnea, Impaired Driving
- Being tested
- Sleep health education provided via a web-based program, Sleep disorder detection and treatment, Optimization of Sleep in Fire Station
- Keywords
- sleep, firefighter, fire, apnea, insomnia, shift, narcolepsy, restless leg, rls, fatigue, Optalert, actigraph, actigraphy, actiwatch, safety, sleepiness, sleepy, work, hours, FEMA
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Sleep Initiation and Maintenance Disorders, Restless Legs Syndrome, Sleep Apnea, Obstructive, Apnea, Narcolepsy, Fatigue, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep health education provided via a web-based programBehavioural
Also called Operation Fight Fatigue, OFF, Comprehensive Fatigue Management Training 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.
Sleep disorder detection and treatmentOther
Also called Operation Fight Fatigue, OFF, Comprehensive Fatigue Management Training Program
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.
Optimization of Sleep in Fire StationOther
Also called Operation Fight Fatigue, OFF, Comprehensive Fatigue Management Training Program
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sleep health education provided via a web-based program; Other: Sleep disorder detection and treatment; Other: 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. Receives: Behavioral: Sleep health education provided via a web-based program; Other: Sleep disorder detection and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Up to 1 year
Employment verification as a firefighter of all participants
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.
Measured: Up to 1 year
Composite of firefighter health information
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 620 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
- Charles Czeisler, PH.D., M.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672502
- Sponsor's protocol ID
- EMW-2010-FP-00521
- Status last verified
- Mar 2016
- First submitted
- 16 Aug 2012
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fire Fighter Fatigue Management Program: Operation Fight Fatigue
- ClinicalTrials.gov ID
- NCT01672502
- Acronym / sponsor ID
- EMW-2010-FP-00521
- Conditions
- Shift-Work Sleep Disorder, Insomnia, Restless Leg Syndrome, Obstructive Sleep Apnea, Impaired Driving
- Keywords
- sleep, firefighter, fire, apnea, insomnia, shift, narcolepsy, restless leg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Federal Emergency Management Agency
- Study start
- Sep 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Federal Emergency Management Agency 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Sleep health education provided via a web-based program, Other: Sleep disorder detection and treatment, Other: Optimization of Sleep in Fire StationFirefighters 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. |
| Control | Active comparator | Behavioral: Sleep health education provided via a web-based program, Other: Sleep disorder detection and treatmentFirefighters 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be a fire department employee at a participating fire department.
Key exclusion criteria (2 listed)
- May not be 17 years of age or younger.
- Will not be included if not a firefighter.
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 health education provided via a web-based programAlso: Operation Fight Fatigue, OFF, Comprehensive Fatigue Management Training ProgramAll 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. | Behavioural | Control, Intervention |
| Sleep disorder detection and treatmentAlso: Operation Fight Fatigue, OFF, Comprehensive Fatigue Management Training ProgramFirefighters 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 | Control, Intervention |
| Optimization of Sleep in Fire StationAlso: Operation Fight Fatigue, OFF, Comprehensive Fatigue Management Training ProgramFirst, 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 | Intervention |
Primary outcome
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.
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
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.
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.
3 secondary outcomes
Documentation of motor vehicle crashes (MVC), and reported injuries
Time frame: Up to 1 year
Employment verification as a firefighter of all participants
Time frame: Up to 1 year
Composite of firefighter health information
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
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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.
Charles Czeisler, PH.D., M.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 health education provided via a web-based program, Sleep disorder detection and treatment and Optimization of Sleep in Fire Station 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 1 inclusion and 2 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 17 Mar 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.). The study lists 3 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 17 Mar 2016.