Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability ...
1 other identifier
interventional
2,400
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2027
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2020
CompletedFirst Posted
Study publicly available on registry
August 19, 2020
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
Study Completion
Last participant's last visit for all outcomes
December 31, 2029
February 7, 2025
February 1, 2025
3 years
August 17, 2020
February 6, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Evaluation of sleep disorder
Evaluation of sleep disorder
12 months (on end-of-year questionnaire)
Diagnosis of sleep disorder
Diagnosis of sleep disorder
12 months (on end-of-year questionnaire)
Treatment of sleep disorder
Treatment of sleep disorder
12 months (on end-of-year questionnaire)
Injuries
Injuries
Over 12 months (The number of injuries as documented in the fire department database)
Disability days
Disability days
Over 12 months (The number of injuries as documented in the fire department database)
Secondary Outcomes (2)
Motor vehicle crashes
Over 12 months, reported on monthly surveys
Near crashes
Over 12 months, reported on monthly surveys
Study Arms (2)
Experimental (Early Education)
EXPERIMENTALFirefighters 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 INTERVENTIONFirefighters in station randomized to the control condition will not receive SHEP prior to the data collection.
Interventions
Sleep Health Education Program (SHEP) including screening for common sleep disorders
Eligibility Criteria
You may qualify if:
- Firefighters working in one of the two fire departments selected for study
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 17, 2020
First Posted
August 19, 2020
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
February 7, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- After publication of results.
- Access Criteria
- Per the NIH Policy on Data Sharing, we will make the database available to other investigators following publication of the final study results. The database will not contain identifying information per the regulations outlined in HIPPA, and permission will be obtained from study participants to share their data with researchers outside the Brigham and Women's Hospital. Per Partners HealthCare System 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, e.g., through a formal Data Use Agreement (DUA) negotiated by a Partners office or a template letter agreement signed by the sharing and receiving PIs.
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.