Sleep DisorderNCT04519177
Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ...
A study testing Sleep Health Education Program (SHEP) in people with Sleep Disorder, run by Brigham and Women's Hospital.
Trial summary
The investigators have shown that sleep health education and sleep disorders screening improve health and safety of employees. There is potential to increase the benefits of the sleep health education and screening program if more firefighters are evaluated, diagnosed and referred for treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- Sleep Health Education Program (SHEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Firefighters working in one of the two fire departments selected for study
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jason Sullivan contact
About this study
Official title: Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability
The investigators have shown that sleep health education and sleep disorders screening improve health and safety of employees. There is potential to increase the benefits of the sleep health education and screening program if more firefighters are evaluated, diagnosed and referred for treatment. Investigators will evaluate whether firefighters in stations randomized to participate in the Sleep Health and Education Program (SHEP) intervention will have improved health and safety outcomes as compared to firefighters in stations randomized to the control condition.
- Conditions
- Sleep Disorder
- Being tested
- Sleep Health Education Program (SHEP)
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Health Education Program (SHEP)Behavioural
Sleep Health Education Program (SHEP) including screening for common sleep disorders
| Study group | Role | What they receive |
|---|---|---|
| Experimental (Early Education) | Experimental | Firefighters in station randomized to the experimental (early education) will receive the sleep health education program (SHEP) including screening for common sleep disorders. Those found at high risk will be given information about seeking further evaluation, diagnosis and treatment, if necessary. Receives: Behavioral: Sleep Health Education Program (SHEP) |
| Control (Later education) | No intervention | Firefighters in station randomized to the control condition will not receive SHEP prior to the data collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of sleep disorder
Evaluation of sleep disorder
Measured: 12 months (on end-of-year questionnaire)
Diagnosis of sleep disorder
Diagnosis of sleep disorder
Measured: 12 months (on end-of-year questionnaire)
Treatment of sleep disorder
Treatment of sleep disorder
Measured: 12 months (on end-of-year questionnaire)
Injuries
Injuries
Measured: Over 12 months (The number of injuries as documented in the fire department database)
Disability days
Disability days
Measured: Over 12 months (The number of injuries as documented in the fire department database)
Secondary outcomes (2)
Motor vehicle crashes
Motor vehicle crashes (exploratory aim)
Measured: Over 12 months, reported on monthly surveys
Near crashes
Near crashes (exploratory aim)
Measured: Over 12 months, reported on monthly surveys
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura K. Barger, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519177
- Sponsor's protocol ID
- 2020P002448
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2020
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results derived from the proposed work will be shared through presentation at research conferences as well as publication in peer-reviewed journals. We or the journal will submit an electronic version of all final manuscripts upon acceptance for publication to PubMed Central database, in compliance with NIH Policy. If required, published data will also be deposited in publicly available databases. Per NIH Policy, we will make the database available to other investigators following publication of the final study results. The database will not contain identifying information per HIPAA regulations and permission will be obtained from participants to share their data with researchers outside the BWH. Per Partners policies, any investigator or entity requesting the data must request the data in writing in an agreement outlining how the data will be used, protected, and maintained.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability
- ClinicalTrials.gov ID
- NCT04519177
- Acronym / sponsor ID
- 2020P002448
- Conditions
- Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 Aug 2020 (actual)
- 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 investigators have shown that sleep health education and sleep disorders screening improve health and safety of employees. There is potential to increase the benefits of the sleep health education and screening program if more firefighters are evaluated, diagnosed and referred for treatment. Investigators will evaluate whether firefighters in stations randomized to participate in the Sleep Health and Education Program (SHEP) intervention will have improved health and safety outcomes as compared to firefighters in stations randomized to the control condition.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental (Early Education) | Experimental | Behavioral: Sleep Health Education Program (SHEP)Firefighters in station randomized to the experimental (early education) will receive the sleep health education program (SHEP) including screening for common sleep disorders. Those found at high risk will be given information about seeking further evaluation, diagnosis and treatment, if necessary. |
| Control (Later education) | No intervention | –Firefighters in station randomized to the control condition will not receive SHEP prior to the data collection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Firefighters working in one of the two fire departments selected for study
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 Health Education Program (SHEP)Sleep Health Education Program (SHEP) including screening for common sleep disorders | Behavioural | Experimental (Early Education) |
Primary outcome
Evaluation of sleep disorder
Time frame: 12 months (on end-of-year questionnaire)
Evaluation of sleep disorder
Diagnosis of sleep disorder
Time frame: 12 months (on end-of-year questionnaire)
Diagnosis of sleep disorder
Treatment of sleep disorder
Time frame: 12 months (on end-of-year questionnaire)
Treatment of sleep disorder
Injuries
Time frame: Over 12 months (The number of injuries as documented in the fire department database)
Injuries
Disability days
Time frame: Over 12 months (The number of injuries as documented in the fire department database)
Disability days
2 secondary outcomes
Motor vehicle crashes
Time frame: Over 12 months, reported on monthly surveys
Near crashes
Time frame: Over 12 months, reported on monthly surveys
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. Results derived from the proposed work will be shared through presentation at research conferences as well as publication in peer-reviewed journals. We or the journal will submit an electronic version of all final manuscripts upon acceptance for publication to PubMed Central database, in compliance with NIH Policy. If required, published data will also be deposited in publicly available databases. Per NIH Policy, we will make the database available to other investigators following publication of the final study results. The database will not contain identifying information per HIPAA regulations and permission will be obtained from participants to share their data with researchers outside the BWH. Per Partners policies, any investigator or entity requesting the data must request the data in writing in an agreement outlining how the data will be used, protected, and maintained.
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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.
Jason Sullivan contact
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Health Education Program (SHEP) in people with Sleep Disorder, run by Brigham and Women's Hospital.
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: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Barger, PhD (530-753-2876, lkbarger@hms.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of sleep disorder (time frame: 12 months (on end-of-year questionnaire)). The study lists 5 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 13 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.