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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00246051
Other study ID # SL00067
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated August 13, 2013
Start date November 2005
Est. completion date December 2010

Study information

Verified date August 2013
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

Police officers work some of the most demanding schedules known, which increases their risk of sleep deprivation and sleep disorders. The need to work frequent overnight shifts and long work weeks leads to acute and chronic partial sleep deprivation as well as misalignment of circadian phase. The public expects officers to perform flawlessly, but sleep deprivation and unrecognized sleep disorders significantly degrade cognition, alertness, reaction time and performance. In addition, both acute and chronic sleep deprivation adversely affect personal health, increasing the risk of gastrointestinal and heart disease, impairing glucose metabolism, and substantially increasing the risk of injury due to motor vehicle crashes.

We propose to conduct a randomized, prospective study of the effect on the safety, health, and performance of a police department of a Comprehensive Police Fatigue Management Program (CPFMP) consisting of the following interventions:

1. identification and treatment of police with sleep disorders;

2. caffeine re-education; and

3. initiation of a sleep, health and safety educational program.

These interventions were chosen because we believe them most likely to lead to measurable improvements on work hours, health, safety, and job performance, and because they are cost effective. The success of the CPFMP will be assessed through an experimental comparison with a standard treatment group that will receive sleep education in the absence of any accompanying interventions. The overall goal of our team will be sleep health detection and treatment program that can be disseminated to practitioners, policymakers and researchers nationwide to reduce police officer fatigue and stress; enhance the ability of officers to cope with shift schedules; improve the health, safety and performance of law enforcement officers; and thereby improve public safety.


Recruitment information / eligibility

Status Completed
Enrollment 683
Est. completion date December 2010
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Active Sworn Police Officers

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleep Hygiene Education
An education program, consisting of materials from experts in the field of fatigue management, will be provided to all police officers in the intervention group. Videotapes, slides, handouts and other educational material will be compiled to create a variety of information sources for police officers. Examples of materials to be incorporated into this training program would be the Operation Healthy Sleep Training Video, powerpoint created by the Harvard Work Hours, Health and Safety Group and pamphlets provided by the American Academy of Sleep Medicine.
Other:
Expert-Led Sleep Disorders Screening and Treatment
Expert-led sleep disorder screening and treatment will consist of visiting police stations and presenting an information session about Operation Healthy Sleep. The session will take place during work time. During the session, we will invite officers to take the Operation Healthy Sleep survey. All subjects that answer the survey indicating that they are at high risk on the Berlin Questionnaire will be contacted to arrange an initial appointment at our OSA research clinic. If they don't meet the criteria they will be disempanelled. Positive on the Berlin Questionnaire Clinic visit, exam with a physician, given a home diagnostic device (HDD) High risk on HDD, seen by physician, given a CPAP machine Follow up visit after 2-3 weeks, CPAP data downloaded and reviewed Contacted by a sleep health clinic at 3, 6, 12 months After 12 months subject will be referred to their primary care physician
Online Sleep Disorders Screening
Online sleep disorder screening will be available to all police officers nation-wide through the Operation Healthy Sleep survey. All subjects that answer the survey questions indicating that they are at high risk of a sleep disorder will be notified either online following the completion of the survey or by email or a letter. Treatment and follow up will not be conducted for individuals who screen positive on the online version of the Operation Healthy Sleep survey.

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Motor vehicle accidents as a function of miles traveled 05/2005 - 07/2009 No
Primary Number of on-the-job injuries 05/2005 - 07/2009 No
Primary Number of citations issued 05/2005 - 07/2009 No
Primary Number of arrests made 05/2005 - 07/2009 No
Primary Number of warnings issued 05/2005 - 07/2009 No
Primary Number of officer-initiated vehicle assists 05/2005 - 07/2009 No
Primary Number of sick leave days 05/2005 - 07/2009 No
Primary Sleep duration 05/2005 - 07/2009 No
Primary Sleep quality 05/2005 - 07/2009 No
Primary Alertness 05/2005 - 07/2009 No
Primary Performance 05/2005 - 07/2009 No
Secondary Job satisfaction 05/2005 - 07/2009 No
Secondary Burnout 05/2005 - 07/2009 No
Secondary Works hours 05/2005 - 07/2009 No
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