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Not yet recruitingNCT07927348CODE3Updated Nov 10, 2026

The Sleep Health and Fatigue Education Program for the Administrators of Emergency Medical Services Agencies

An interventional study of Sleep Health/Fatigue Education Program in Sleep Health and Fatigue, sponsored by University of Pittsburgh. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research

Updated Nov 10, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
184
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The investigators aim to pilot test an education program designed to address workplace sleep health and fatigue. The education program targets employers (administrators) of United States (U.S.)-based emergency medical services (EMS) and fire department operations. Data from this pilot, proof-of-concept study will provide data to inform larger studies.

Read the detailed description

Poor sleep and fatigue are widespread among first responder personnel such as EMTs and paramedics. Prior research shows that greater than 80% of frontline EMS personnel report fatigue. Unfortunately, there is no gold standard education program specifically for the administrators of EMS / first responder operations that raises awareness of current evidence based guidelines for sleep health and fatigue risk management.

The investigators aim to pilot test an education program specifically designed for employers (administrators) of U.S.-based EMS / fire operations. Data from this pilot study will provide much needed data regarding this type of education program and guide future, larger studies focused on poor sleep and fatigue in first responder operations.

02

Conditions studied

  • Sleep Health
  • Fatigue

Browse trials for

Keywords

  • Workplace fatigue
  • Sleep Health
  • Shift work
  • Education and Training
03

In context

Fatigue

2,229 studies on the registry are indexed under Fatigue; 426 are open to participants now.

This study's planned enrollment of 184 is above the median of 54 across 1,757 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-

EMS administrators are eligible if they are:

  • 18 years of age or older
  • Actively working as EMS administrator at any type of EMS agency

Frontline EMS personnel are eligible if they are:

  • 18 years of age or older
  • Actively working a minimum of 1 shift per week on the ambulance
  • Affiliated with an agency involved in this research study based on an EMS administrator signing up first

Exclusion criteria

Exclusion Criteria:

-

EMS administrators are not eligible if they are:

  • Affiliated with a first responder organization that does not employ frontline EMS clinicians
  • Daily operations do not involve frontline EMS personnel operating ambulances and taking care of patients either in an emergent or non-emergent situation 24 hours a day
  • Administrator does not provide direct oversight of frontline EMS personnel

Frontline EMS personnel are not eligible if they:

  • Are not affiliated with an EMS operation that is enrolled in this research study by an EMS administrator at their agency/operation
  • Do not work at least 1 shift per week at the agency as a frontline EMS personnel taking care of patients in emergent or non-emergent situations
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
184 participants (estimated)

Study arms

  • Experimental
    EMS Administrators

    A short education program focused on importance of sleep health and fatigue delivered to emergency medical services administrators (EMS Administrator Arm)

    Other: Sleep Health/Fatigue Education Program

  • Experimental
    Frontline EMS personnel

    Frontline EMS personnel employed at EMS agencies where EMS administrators are exposed to the Sleep Health and Fatigue Education Program

    Other: Sleep Health/Fatigue Education Program

Interventions

  • OtherSleep Health/Fatigue Education Program

    A short education program focused on importance of sleep health and fatigue delivered to emergency medical services administrators

    Also known as: Sleep health and fatigue education program

06

What researchers measure

Primary outcomes

  1. Change in policy (EMS Administrators)

    A single question: "Did participant's EMS agency create a new or change an existing policy after watching the CODE3 Sleep \& Fatigue in EMS Program? \_\_Yes. \_\_No."

    Time frame: At baseline and at 6-9 months follow-up

  2. Change in sleep quality (Frontline EMS personnel)

    Sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) among frontline EMS personnel. The PSQI solicits self-reported responses on 19 survey items that primarily use a Likert type response scale that are weighted using prescribed formulas and reference the prior month. Scores range from 0 - 21 with scores 6- 21 indicating poor sleep quality. A PSQI score decrease \> = 3 points is considered clinically meaningful and associated with a reduction in signs and symptoms of poor sleep.

    Time frame: At baseline and at 6-9 months follow-up

Secondary outcomes

  1. Change in sleep health (Frontline EMS personnel)

    Sleep health as measured by the RU-SATED survey instrument (Regularity, Satisfaction, Alertness, Timing, Efficiency, and Duration). The survey solicits self-reported responses on a Likert type response scale to 6 items that reference the prior month. Six items, each scored 0-2. Response of 0 = Never/rarely; 1 = Sometimes; 2 = Usually/always. Total score = sum of six items. There are no universally established clinical cut points for the RU-SATED; however, higher scores suggest good sleep health.

    Time frame: At baseline and at 6-9 months follow-up

  2. Change in daytime sleepiness (Frontline EMS personnel)

    Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS). The ESS solicits self-reported responses on a Likert type scale to 8 items. Items are scored using a prescribed algorithm with scores ranging from 0 - 24. Higher scores indicate greater daytime sleepiness. A score decrease of \> = 2 points is considered clinically meaningful and associated with a reduction in signs and symptoms of daytime sleepiness.

    Time frame: At baseline and at 6-9 months follow-up

  3. Change in fatigue (Frontline EMS personnel)

    Fatigue (mental and physical) is measured with the Chalder Fatigue Questionnaire (CFQ). The CFQ solicits self-reported responses on a Likert type response scale to 11 survey items. One approach to scoring includes: Less than usual = 0; No more than usual = 1; More than usual = 2; Much more than usual = 3. The more commonly used approach to scoring (bimodal approach) includes: Less than usual = 0; No more than usual = 0; More than usual = 1; Much more than usual = 1. Scores \> = 4 suggest severe mental and physical fatigue.

    Time frame: At baseline and at 6-9 months follow-up

  4. Change in chronic fatigue (Frontline EMS personnel)

    Chronic fatigue (CF) is measured with the CF sub-scale survey instrument of the Occupational Fatigue Exhaustion/Recovery Scale (OFER-15). Responses for the CF sub-scale are solicited for 5 items using a Likert response scale: 0 = strongly disagree to 6 = strongly agree. Scoring involves summing the 5 items, dividing by 30 and then multiplying by 100. Scores range from 0 to 100. Final scores 0 - 25 suggest Low CF; scores 26 - 50 suggest Low to Moderate CF; scores 51 - 75 suggest Moderate to High CF; scores 76 to 100 suggest High CF.

    Time frame: At baseline and at 6-9 months follow-up

  5. Change in acute fatigue (Frontline EMS personnel)

    Acute fatigue (AF) is measured with the AF sub-scale survey instrument of the Occupational Fatigue Exhaustion/Recovery Scale (OFER-15). Responses for the AF sub-scale are solicited for 5 items using a Likert response scale: 0 = strongly disagree to 6 = strongly agree. Scoring involves summing the 5 items, dividing by 30 and then multiplying by 100. Scores range from 0 to 100. Final scores 0 - 25 suggest Low AF; scores 26 - 50 suggest Low to Moderate AF; scores 51 - 75 suggest Moderate to High AF; scores 76 to 100 suggest High AF. Two items of the AF sub-scale are reverse scored/coded.

    Time frame: At baseline and at 6-9 months follow-up

  6. Change in Intershift Recovery (Frontline EMS personnel)

    Intershift Recovery between shifts (IR) is measured with the IR sub-scale survey instrument of the Occupational Fatigue Exhaustion/Recovery Scale (OFER-15). Responses for the IR sub-scale are solicited for 5 items using a Likert response scale: 0 = strongly disagree to 6 = strongly agree. Scoring involves summing the 5 items, dividing by 30 and then multiplying by 100. Scores range from 0 to 100. Final scores 0 - 25 suggest Low IR; scores 26 - 50 suggest Low to Moderate IR; scores 51 - 75 suggest Moderate to High IR; scores 76 to 100 suggest High IR. Three items of the IR sub-scale are reverse scored/coded.

    Time frame: At baseline and at 6-9 months follow-up

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — De-identified data and a data dictionary will be shared with other researchers (investigators) on a case-by-case basis and based on the required procedures and guidance as outlined by the University of Pittsburgh in the Data Use Agreements provided by the Office of Sponsored Programs.

Time frame: Requests for sharing data will be reviewed 12 months after publication of the study's main findings by the study investigators.

Access criteria: Requests must adhere to the policies and requirements of the University of Pittsburgh as outlined in Data Use Agreements. De-identified data files and a data dictionary can be shared using University of Pittsburgh approved mechanisms.

Data sharing details ↗ · www.osp.pitt.edu

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Aug 2027, 8 months later.

Of 936 non-industry interventional studies with no phase under Fatigue, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 8 months is below that.

Counting every sponsor, half of 989 studies reached it within 11 months; a quarter within 5 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2026
First posted
Nov 10, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Aug 31, 2027
CompletionEst.
Oct 31, 2027
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07927348
Collaborators
American Academy of Sleep Medicine
Responsible party
Daniel Patterson, PhD, NRP (Professor, University of Pittsburgh) — Principal investigator
First posted
Nov 10, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Aug 31, 2027 (estimated)
Completion
Oct 31, 2027 (estimated)
Last update
Nov 10, 2026

Study contacts

Paul D Patterson, PhD
Contact
pdp3@pitt.edu
412-647-3078
Maureen Morgan
Contact
morganma@upmc.edu
412-647-3078
Paul D Patterson, PhD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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