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Randomized Trial of a Sleep Disorders Program on Firefighter Safety and Disability …

Studies

Study First Submitted Date 2020-08-17
Study First Posted Date 2020-08-19
Last Update Posted Date 2023-07-27
Start Month Year June 1, 2024
Primary Completion Month Year December 31, 2026
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-07-27

Conditions

Sequence: 51805642
Name Sleep Disorder
Downcase Name sleep disorder

Id Information

Sequence: 39867489
Id Source org_study_id
Id Value 2020P002448

Design Groups

Sequence: 55225724 Sequence: 55225725
Group Type Experimental Group Type No Intervention
Title Experimental (Early Education) Title Control (Later education)
Description 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. Description Firefighters in station randomized to the control condition will not receive SHEP prior to the data collection.

Interventions

Sequence: 52127315
Intervention Type Behavioral
Name Sleep Health Education Program (SHEP)
Description Sleep Health Education Program (SHEP) including screening for common sleep disorders

Design Outcomes

Sequence: 176200448 Sequence: 176200449 Sequence: 176200450 Sequence: 176200451 Sequence: 176200452 Sequence: 176200453 Sequence: 176200454
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure Evaluation of sleep disorder Measure Diagnosis of sleep disorder Measure Treatment of sleep disorder Measure Injuries Measure Disability days Measure Motor vehicle crashes Measure Near crashes
Time Frame 12 months (on end-of-year questionnaire) Time Frame 12 months (on end-of-year questionnaire) Time Frame 12 months (on end-of-year questionnaire) Time Frame Over 12 months (The number of injuries as documented in the fire department database) Time Frame Over 12 months (The number of injuries as documented in the fire department database) Time Frame Over 12 months, reported on monthly surveys Time Frame Over 12 months, reported on monthly surveys
Description Evaluation of sleep disorder Description Diagnosis of sleep disorder Description Treatment of sleep disorder Description Injuries Description Disability days Description Motor vehicle crashes (exploratory aim) Description Near crashes (exploratory aim)

Browse Conditions

Sequence: 192014089 Sequence: 192014090 Sequence: 192014091 Sequence: 192014092 Sequence: 192014093
Mesh Term Sleep Wake Disorders Mesh Term Parasomnias Mesh Term Nervous System Diseases Mesh Term Neurologic Manifestations Mesh Term Mental Disorders
Downcase Mesh Term sleep wake disorders Downcase Mesh Term parasomnias Downcase Mesh Term nervous system diseases Downcase Mesh Term neurologic manifestations Downcase Mesh Term mental disorders
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 47978467
Agency Class OTHER
Lead Or Collaborator lead
Name Brigham and Women’s Hospital

Central Contacts

Sequence: 11935194 Sequence: 11935195
Contact Type primary Contact Type backup
Name Laura Barger, PhD Name Jason Sullivan
Phone 530-753-2876
Email lkbarger@hms.harvard.edu Email jsullivan@rics.bwh.harvard.edu
Role Contact Role Contact

Design Group Interventions

Sequence: 67706865
Design Group Id 55225724
Intervention Id 52127315

Eligibilities

Sequence: 30550612
Gender All
Minimum Age 18 Years
Maximum Age 80 Years
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria: Firefighters working in one of the two fire departments selected for study Exclusion Criteria: None
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254231516
Registered In Calendar Year 2020
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Maximum Age Num 80
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 5
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30298984
Allocation Randomized
Intervention Model Sequential Assignment
Observational Model
Primary Purpose Screening
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28677549
Responsible Party Type Principal Investigator
Name Laura K. Barger
Title Principal Investigator
Affiliation Brigham and Women’s Hospital

Ipd Information Types

Sequence: 3314719 Sequence: 3314720 Sequence: 3314721
Name Study Protocol Name Statistical Analysis Plan (SAP) Name Informed Consent Form (ICF)