Obstructive Sleep Apnea Clinical Trial
Official title:
Fire Fighter Fatigue Management Program: Operation Fight Fatigue
Verified date | March 2016 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 620 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Division of Sleep Medicine; Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Federal Emergency Management Agency |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Yes |
Primary | 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 | No |
Primary | 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. | No |
Secondary | 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. | Up to 1 year | No |
Secondary | 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. | Up to 1 year | No |
Secondary | 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. | Up to 1 year | No |
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