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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04519177
Other study ID # 2020P002448
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date December 31, 2026

Study information

Verified date July 2023
Source Brigham and Women's Hospital
Contact Laura Barger, PhD
Phone 530-753-2876
Email lkbarger@hms.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 2400
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Firefighters working in one of the two fire departments selected for study Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleep Health Education Program (SHEP)
Sleep Health Education Program (SHEP) including screening for common sleep disorders

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of sleep disorder Evaluation of sleep disorder 12 months (on end-of-year questionnaire)
Primary Diagnosis of sleep disorder Diagnosis of sleep disorder 12 months (on end-of-year questionnaire)
Primary Treatment of sleep disorder Treatment of sleep disorder 12 months (on end-of-year questionnaire)
Primary Injuries Injuries Over 12 months (The number of injuries as documented in the fire department database)
Primary Disability days Disability days Over 12 months (The number of injuries as documented in the fire department database)
Secondary Motor vehicle crashes Motor vehicle crashes (exploratory aim) Over 12 months, reported on monthly surveys
Secondary Near crashes Near crashes (exploratory aim) Over 12 months, reported on monthly surveys
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