Fire Fighter Fatigue Management Program: Operation Healthy Sleep

Obstructive Sleep Apnea Clinical Trial

Official title:

Fire Fighter Fatigue Management Program: Operation Healthy Sleep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01988129
• Other study ID #: 2009-P-000697
• Status: Completed
• Phase: N/A
• First received: July 27, 2010
• Last updated: July 1, 2015
• Start date: March 2009
• Est. completion date: September 2013

Study information

• Verified date: July 2015
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.'

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:

1. improve the mean total sleep, alertness and cognitive performance of firefighters;

2. improve firefighter safety, as determined by:

1. decreased rates of motor vehicle crashes;

2. decreased on-the-job injuries;

3. improve firefighter performance, as determined by decreased response time;

4. improve firefighters' health, as determined by:

1. diagnosis and treatment of sleep disorders

2. improved general health indices

3. decreased number of 'sick' days

5. improve firefighters' and families' job satisfaction and ability to cope with extended work hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1189
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Non fire department employees

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Impaired Driving
• Injuries
• Insomnia
• Obstructive Sleep Apnea
• Parasomnias
• Restless Leg Syndrome
• Restless Legs Syndrome
• Shift-Work Sleep Disorder
• Sleep Apnea, Obstructive
• Sleep Disorders
• Sleep Disorders, Circadian Rhythm

Intervention

Other:
• Sleep disorders education and screening
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.

Locations

Country	Name	City	State
United States	BWH Division of Sleep Medicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Federal Emergency Management Agency

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire	Firefighters were instructed to attend a mandatory 30-min education training presentation as operations allowed. Following the education, firefighters were invited and encouraged to complete a voluntary sleep disorders screening questionnaire. This questionnaire used validated, self-report screening tools for Obstructive Sleep Apnea (OSA), moderate to severe insomnia, restless legs syndrome and shift work disorder. All of the respondents 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 local American Academy of Sleep Medicine-certified, partnering sleep clinics if they chose to follow-up. Participants were also free to seek medical follow-up elsewhere. Telephone calls were made to all high risk participants to ensure that they were aware of the results, and to facilitate clinic scheduling. Participants were asked to provide voluntary medical records release consent for tracking diagnoses.	Baseline (Study start)	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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.	Baseline to 12 months	No
Secondary	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.	Baseline to 12 months	No
Secondary	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.	Baseline to 12 months	No
Secondary	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.	Baseline to 12 months	No
Secondary	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.	Baseline to 12 months	No
Secondary	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.	Baseline to 12 months	No
Secondary	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.	Baseline to 12 months	No