Sleep DisordersNCT00246051
Comprehensive Police Fatigue Management Program
A study testing Sleep Hygiene Education, Expert-Led Sleep Disorders Screening and Treatment and Online Sleep Disorders Screening in people with Sleep Disorders and Sleep Apnea, Obstructive, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders, Sleep Apnea, Obstructive, Restless Legs Syndrome
- What is being tested?
- Sleep Hygiene Education, Expert-Led Sleep Disorders Screening and Treatment and Online Sleep Disorders Screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 683 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Dec 2010
- 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
- Active Sworn Police Officers
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Testing the Effectiveness of a Comprehensive Fatigue Management for the Police
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:
Read more
- identification and treatment of police with sleep disorders;
- caffeine re-education; and
- 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.
- Conditions
- Sleep Disorders, Sleep Apnea, Obstructive, Restless Legs Syndrome, Sleep Disorders, Circadian Rhythm, Sleep Initiation and Maintenance Disorders
- Being tested
- Sleep Hygiene Education, Expert-Led Sleep Disorders Screening and Treatment, Online Sleep Disorders Screening
- Keywords
- Police, Sleep, Fatigue, Work Hours, Sleep disorder, Performance
- Medical subject headings
- Sleep Wake Disorders, Sleep Apnea, Obstructive, Restless Legs Syndrome, Sleep Disorders, Circadian Rhythm, Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Hygiene EducationBehavioural
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.
Expert-Led Sleep Disorders Screening and TreatmentOther
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 ScreeningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Hygiene Education | Other | Not described Receives: Behavioral: Sleep Hygiene Education |
| Expert-Led Sleep Disorders Screening and Treatment | Other | Not described Receives: Other: Expert-Led Sleep Disorders Screening and Treatment |
| Online Sleep Disorders Screening | Other | Not described Receives: Other: Online Sleep Disorders Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor vehicle accidents as a function of miles traveled
Measured: 05/2005 - 07/2009
Number of on-the-job injuries
Measured: 05/2005 - 07/2009
Number of citations issued
Measured: 05/2005 - 07/2009
Number of arrests made
Measured: 05/2005 - 07/2009
Number of warnings issued
Measured: 05/2005 - 07/2009
Number of officer-initiated vehicle assists
Measured: 05/2005 - 07/2009
Number of sick leave days
Measured: 05/2005 - 07/2009
Sleep duration
Measured: 05/2005 - 07/2009
Sleep quality
Measured: 05/2005 - 07/2009
Alertness
Measured: 05/2005 - 07/2009
Performance
Measured: 05/2005 - 07/2009
Secondary outcomes (3)
Job satisfaction
Measured: 05/2005 - 07/2009
Burnout
Measured: 05/2005 - 07/2009
Works hours
Measured: 05/2005 - 07/2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 683 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Andrew Czeisler, MD, PhD, Brigham and Women's Hospital
- Investigators
- Charles A. Czeisler, Ph.D., M.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246051
- Sponsor's protocol ID
- SL00067
- Status last verified
- Aug 2013
- First submitted
- 13 Sep 2005
- Last updated
- 15 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of a Comprehensive Fatigue Management for the Police
- ClinicalTrials.gov ID
- NCT00246051
- Acronym / sponsor ID
- SL00067
- Conditions
- Sleep Disorders, Sleep Apnea, Obstructive, Restless Legs Syndrome, Sleep Disorders, Circadian Rhythm, Sleep Initiation and Maintenance Disorders
- Keywords
- Police, Sleep, Fatigue, Work Hours, Sleep disorder, Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 683 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 31 Oct 2005 (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.
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:
- identification and treatment of police with sleep disorders;
- caffeine re-education; and
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sleep Hygiene Education | Other | Behavioral: Sleep Hygiene Education |
| Expert-Led Sleep Disorders Screening and Treatment | Other | Other: Expert-Led Sleep Disorders Screening and Treatment |
| Online Sleep Disorders Screening | Other | Other: Online Sleep Disorders Screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active Sworn Police Officers
Key exclusion criteria (1 listed)
- None
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 Hygiene EducationAn 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. | Behavioural | Sleep Hygiene Education |
| Expert-Led Sleep Disorders Screening and TreatmentExpert-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. 1. Positive on the Berlin Questionnaire 2. Clinic visit, exam with a physician, given a home diagnostic device (HDD) 3. High risk on HDD, seen by physician, given a CPAP machine 4. Follow up visit after 2-3 weeks, CPAP data downloaded and reviewed 5. Contacted by a sleep health clinic at 3, 6, 12 months 6. After 12 months subject will be referred to their primary care physician | Other | Expert-Led Sleep Disorders Screening and Treatment |
| Online Sleep Disorders ScreeningOnline 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. | Other | Online Sleep Disorders Screening |
Primary outcome
Motor vehicle accidents as a function of miles traveled
Time frame: 05/2005 - 07/2009
Number of on-the-job injuries
Time frame: 05/2005 - 07/2009
Number of citations issued
Time frame: 05/2005 - 07/2009
Number of arrests made
Time frame: 05/2005 - 07/2009
Number of warnings issued
Time frame: 05/2005 - 07/2009
Number of officer-initiated vehicle assists
Time frame: 05/2005 - 07/2009
Number of sick leave days
Time frame: 05/2005 - 07/2009
Sleep duration
Time frame: 05/2005 - 07/2009
Sleep quality
Time frame: 05/2005 - 07/2009
Alertness
Time frame: 05/2005 - 07/2009
Performance
Time frame: 05/2005 - 07/2009
3 secondary outcomes
Job satisfaction
Time frame: 05/2005 - 07/2009
Burnout
Time frame: 05/2005 - 07/2009
Works hours
Time frame: 05/2005 - 07/2009
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 15 Aug 2013.
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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 A. 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 Hygiene Education, Expert-Led Sleep Disorders Screening and Treatment and Online Sleep Disorders Screening in people with Sleep Disorders and Sleep Apnea, Obstructive, 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 1 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 15 Aug 2013. 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?
Motor vehicle accidents as a function of miles traveled (time frame: 05/2005 - 07/2009). The study lists 11 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 15 Aug 2013.