Sleep DisordersNCT00207285
Sleep Disorders Management, Health and Safety in Police
A study testing Sleep Hygiene Education and Screening and Treatment of Sleep Disorders in people with Sleep Disorders and Sleep Apnea, Obstructive, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of the study is to test the effect of a sleep disorders detection and treatment program for police officers on their safety, quality of life, and job performance. The program is called Operation Healthy Sleep. 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 and Screening and Treatment of Sleep Disorders
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 731 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Sep 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
The purpose of the study is to test the effect of a sleep disorders detection and treatment program for police officers on their safety, quality of life, and job performance. The program is called Operation Healthy Sleep. We will develop and test a sleep health detection and treatment program that we aim to apply nationwide to reduce police officer fatigue and stress; enhance the ability of officers and their families to cope with police work; improve the health, safety and performance of law enforcement officers; and thereby improve public safety. Part of this program will include a questionnaire asking about about work hours and health related issues. We will then look at how these survey data relate with data on police officer safety and job performance that we are collecting through police department's databases.
Sleep disorders are common and treatable, but often remain undiagnosed and untreated. Police officers work some of the most demanding schedules known, which increases their risk of sleep disorders. The public expects officers to perform flawlessly, but unrecognized sleep disorders lead to severe disruption of sleep, which significantly reduces an individual's ability to think clearly and perform well. In addition, sleep loss and sleep disruption affect personal health, increasing the risk of gastrointestinal and cardiovascular. We also know that sleep loss increases the risk of injury due to motor vehicle crashes.
Read more
The goals of Operation Healthy Sleep are to improve officers' health, safety, and performance by reducing the impact of fatigue.
The study will take place over two years. In the first year, half of the police officers will take part in Operation Healthy Sleep, and in the second year, the second half will participate. We will carefully select the year 1 and year 2 groups so that the data collected across the two years can be validly compared.
Read the detailed description
Information Session and Surveys We will visit police stations and present an information session about Operation Healthy Sleep. The session will take place during work time. During this session, we will also provide a short education session aimed to help officers to improve their sleep habits and alertness. During the session, we will invite officers to take part in Operation Healthy Sleep.
If the officer agrees to take part, he/she will be asked to provide informed consent, and then complete a survey. The survey is comprehensive and includes questions regarding work schedules, past medical history, health habits, accidents, quality of life, and mood. The survey will also include a screening test to see if they might have a sleeping disorder. The total time commitment involved in attending the information/education session and completing the survey will be about 1 to 2 hours.
Officers will be asked to provide email address and other contact information. Officers will then receive information on how to link to our monthly web-based nationwide survey. The brief monthly surveys include questions regarding work schedules, accidents and injuries, health, quality of life, and mood. The survey should take about 10-15 minutes to complete each month.
Finally, a version of the survey will be completed at the end of each year until the study is completed (i.e. at most, two years). These yearly surveys will be completed during regular work time.
During the study, we will be tracking work hours, accidents, and job performance of all officers using the police department's computerized and paper records. Data collected through this system may be compared with other data we collect from officers directly. Protection of officers' confidentiality will be our highest priority.
Assessment and Treatment of Sleep Disorders After the initial information/education session is completed, we will review responses to the survey to check whether officers are at risk of having a sleep disorder. If officers are found to be at risk, we will contact them and recommend that they undergo assessment and, if necessary, treatment by a physician or sleep specialist. We will provide the officer with referrals to local sleep disorders testing and treatment centers and physicians. Officers are free to choose another sleep disorders specialist or another physician if they prefer.
- Conditions
- Sleep Disorders, Sleep Apnea, Obstructive, Restless Legs Syndrome, Sleep Disorders, Circadian Rhythm, Sleep Initiation and Maintenance Disorders
- Being tested
- Sleep Hygiene Education, Screening and Treatment of Sleep Disorders
- 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
Baseline general meetings with officers in intervention districts, in which we will provide an introductory program on optimal caffeine use (caffeine re-education) and sleep hygiene, as these are cost-effective measures that may effectively address difficulties adjusting to night work, and low-grade sleep disorders such as mild shift work sleep disorder across the cohort as a whole.
Screening and Treatment of Sleep DisordersProcedure or surgery
All individuals who screen positive in the questionnaires on the baseline survey will be referred to one of the physicians at Sleep HealthCenters® or other sleep clinics in Massachusetts. Individuals will be paid $40 for attending an initial consultation visit with a sleep clinician and $400 if they are then asked to undergo an overnight sleep study and they complete the sleep study. Individuals will also be asked to wear an ApneaLink device for 2 nights at home and for 1 night during the overnight visit at Sleep HealthCenters®. Subjects may be asked to wear the ApneaLink device for more than 2 nights if there are not 4 hours of usable data each night. If the data is inadequate, subjects will be asked to wear the device until 4 hours of usable data on 2 nights is achieved. The ApneaLink device is an FDA approved sleep-screening tool that is used to identify individuals that are at risk for Obstructive Sleep Apnea Syndrome.
| Study group | Role | What they receive |
|---|---|---|
| In Person Training | Other | These firefighters received the sleep education and sleep disorders screening in person by one of our research staff. Receives: Behavioral: Sleep Hygiene Education; Procedure: Screening and Treatment of Sleep Disorders |
| Train the Trainer | Other | These firefighters received the education and sleep disorder screening in person with someone taught by our research staff. Receives: Behavioral: Sleep Hygiene Education; Procedure: Screening and Treatment of Sleep Disorders |
| Online Group | Other | These firefighters took the sleep disorder screening and education online. Receives: Behavioral: Sleep Hygiene Education; Procedure: Screening and Treatment of Sleep Disorders |
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 posted21 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionSep 2010
- Study completionSep 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
- 731 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, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207285
- Sponsor's protocol ID
- 1R01OH008496
- Status last verified
- Mar 2016
- First submitted
- 13 Sep 2005
- Last updated
- 17 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disorders Management, Health and Safety in Police
- ClinicalTrials.gov ID
- NCT00207285
- Acronym / sponsor ID
- 1R01OH008496
- 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
- 731 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 Sep 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.
The purpose of the study is to test the effect of a sleep disorders detection and treatment program for police officers on their safety, quality of life, and job performance. The program is called Operation Healthy Sleep. We will develop and test a sleep health detection and treatment program that we aim to apply nationwide to reduce police officer fatigue and stress; enhance the ability of officers and their families to cope with police work; improve the health, safety and performance of law enforcement officers; and thereby improve public safety. Part of this program will include a questionnaire asking about about work hours and health related issues. We will then look at how these survey data relate with data on police officer safety and job performance that we are collecting through police department's databases.
Sleep disorders are common and treatable, but often remain undiagnosed and untreated. Police officers work some of the most demanding schedules known, which increases their risk of sleep disorders. The public expects officers to perform flawlessly, but unrecognized sleep disorders lead to severe disruption of sleep, which significantly reduces an individual's ability to think clearly and perform well. In addition, sleep loss and sleep disruption affect personal health, increasing the risk of gastrointestinal and cardiovascular. We also know that sleep loss increases the risk of injury due to motor vehicle crashes.
The goals of Operation Healthy Sleep are to improve officers' health, safety, and performance by reducing the impact of fatigue.
The study will take place over two years. In the first year, half of the police officers will take part in Operation Healthy Sleep, and in the second year, the second half will participate. We will carefully select the year 1 and year 2 groups so that the data collected across the two years can be validly compared.
Detailed description
Information Session and Surveys We will visit police stations and present an information session about Operation Healthy Sleep. The session will take place during work time. During this session, we will also provide a short education session aimed to help officers to improve their sleep habits and alertness. During the session, we will invite officers to take part in Operation Healthy Sleep.
If the officer agrees to take part, he/she will be asked to provide informed consent, and then complete a survey. The survey is comprehensive and includes questions regarding work schedules, past medical history, health habits, accidents, quality of life, and mood. The survey will also include a screening test to see if they might have a sleeping disorder. The total time commitment involved in attending the information/education session and completing the survey will be about 1 to 2 hours.
Officers will be asked to provide email address and other contact information. Officers will then receive information on how to link to our monthly web-based nationwide survey. The brief monthly surveys include questions regarding work schedules, accidents and injuries, health, quality of life, and mood. The survey should take about 10-15 minutes to complete each month.
Finally, a version of the survey will be completed at the end of each year until the study is completed (i.e. at most, two years). These yearly surveys will be completed during regular work time.
During the study, we will be tracking work hours, accidents, and job performance of all officers using the police department's computerized and paper records. Data collected through this system may be compared with other data we collect from officers directly. Protection of officers' confidentiality will be our highest priority.
Assessment and Treatment of Sleep Disorders After the initial information/education session is completed, we will review responses to the survey to check whether officers are at risk of having a sleep disorder. If officers are found to be at risk, we will contact them and recommend that they undergo assessment and, if necessary, treatment by a physician or sleep specialist. We will provide the officer with referrals to local sleep disorders testing and treatment centers and physicians. Officers are free to choose another sleep disorders specialist or another physician if they prefer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In Person Training | Other | Behavioral: Sleep Hygiene Education, Procedure: Screening and Treatment of Sleep DisordersThese firefighters received the sleep education and sleep disorders screening in person by one of our research staff. |
| Train the Trainer | Other | Behavioral: Sleep Hygiene Education, Procedure: Screening and Treatment of Sleep DisordersThese firefighters received the education and sleep disorder screening in person with someone taught by our research staff. |
| Online Group | Other | Behavioral: Sleep Hygiene Education, Procedure: Screening and Treatment of Sleep DisordersThese firefighters took the sleep disorder screening and education online. |
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 EducationBaseline general meetings with officers in intervention districts, in which we will provide an introductory program on optimal caffeine use (caffeine re-education) and sleep hygiene, as these are cost-effective measures that may effectively address difficulties adjusting to night work, and low-grade sleep disorders such as mild shift work sleep disorder across the cohort as a whole. | Behavioural | In Person Training, Online Group, Train the Trainer |
| Screening and Treatment of Sleep DisordersAll individuals who screen positive in the questionnaires on the baseline survey will be referred to one of the physicians at Sleep HealthCenters® or other sleep clinics in Massachusetts. Individuals will be paid $40 for attending an initial consultation visit with a sleep clinician and $400 if they are then asked to undergo an overnight sleep study and they complete the sleep study. Individuals will also be asked to wear an ApneaLink device for 2 nights at home and for 1 night during the overnight visit at Sleep HealthCenters®. Subjects may be asked to wear the ApneaLink device for more than 2 nights if there are not 4 hours of usable data each night. If the data is inadequate, subjects will be asked to wear the device until 4 hours of usable data on 2 nights is achieved. The ApneaLink device is an FDA approved sleep-screening tool that is used to identify individuals that are at risk for Obstructive Sleep Apnea Syndrome. | Procedure or surgery | In Person Training, Online Group, Train the Trainer |
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 17 Mar 2016.
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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, Harvard Medical School
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 and Screening and Treatment of Sleep Disorders 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 17 Mar 2016. 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 17 Mar 2016.