Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01988129
Other study ID # 2009-P-000697
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05857384 - Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs Phase 1
Recruiting NCT04547543 - Follow-up of Apneic Patients by Visio-consultation N/A
Recruiting NCT05371509 - Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study N/A
Completed NCT02515357 - Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea N/A
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Active, not recruiting NCT03189173 - Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea Phase 2
Completed NCT04084899 - The Effect of CPAP on Lung Hyperinflation in Patients With OSA
Completed NCT03032029 - Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Recruiting NCT04028011 - Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
Recruiting NCT06047353 - Community Health Advocates for Motivating PAP Use in Our Neighborhoods. N/A
Completed NCT05253963 - Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea N/A
Recruiting NCT06029959 - Stroke and CPAP Outcome Study 3 N/A
Recruiting NCT06150352 - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Completed NCT03589417 - Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
Recruiting NCT04335994 - ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing N/A
Withdrawn NCT04063436 - Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea N/A
Recruiting NCT05385302 - Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
Recruiting NCT04572269 - Metabolomics of Obstructive Sleep Apnea
Not yet recruiting NCT06467682 - 12-week Tele-exercise Program in Patients With OSA N/A
Withdrawn NCT04011358 - Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study N/A