Sleep QualityNCT04218279
The EMS Sleep Health Study: A Randomized Controlled Trial
A study testing Sleep Health Education in people with Sleep Quality and Fatigue, run by University of Pittsburgh at 1 site in United States.
Trial summary
The experiment seeks to determine the impact of a sleep health and fatigue education and training program on diverse indicators of sleep and fatigue among Emergency Medical Services (EMS) personnel. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality, Fatigue
- What is being tested?
- Sleep Health Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 678 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- EMS Personnel:
- 18 years of age or older
- Currently working as an EMS clinician
- Working a minimum of one shift a week
- Working \& residing in the United States
- Working at one of the EMS organizations that agreed to participate in this study
- Have a cellular, mobile, or smart phone that can send and receive text messages
- Willing to answer online surveys and respond to text-message queries for seven days in a row every third week of the month for a total of 24 weeks/6 months
Who cannot join
- EMS Personnel:
- Individuals <18 years of age
- Not currently working as an EMS clinician
- Does not work a minimum of one shift a week
- Does not work and/reside in the United States
- Does not work at one of the EMS organizations that agreed to participate in this study
- Does not have a cellular, mobile, or smart phone that can send and receive text messages
- Is not willing to answer online surveys and respond to text-message queries for seven days in a row every third week of the month for a total of 24 weeks/6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: The EMS Sleep Health and Fatigue Study: A Randomized Controlled Trial
The experiment seeks to determine the impact of a sleep health and fatigue education and training program on diverse indicators of sleep and fatigue among Emergency Medical Services (EMS) personnel. The overarching goals of this research study are to [1] enhance our understanding of the relationships between shift work, sleep, and fatigue in EMS operations; and [2] determine whether or not providing education and training to EMS personnel on the importance of sleep health and dangers of fatigue impact indicators of sleep and fatigue. The investigators will accomplish these goals by using a cluster-randomized trial study design with a wait-list control group.
Read the detailed description
The overarching goals of this research study are to:
- enhance our understanding of the relationships between shift work, sleep, and fatigue in EMS operations; and
- determine whether or not providing education and training to EMS personnel on the importance of sleep health and dangers of fatigue impact indicators of sleep and fatigue.
The investigators will recruit EMS nationwide for EMS agencies to participate in this study and focus on moderately sized EMS agencies with between 50 and 300 employees (yet we will not outright exclude smaller or larger organizations). Agencies that run dual ground-based and air-medical EMS services are eligible. Maximum enrollment at the agency-level is n=30 EMS agencies. Agencies will be randomized upon enrollment to one of two arms: [1] Intervention group; or [2] the Wait-List control group. The intervention group will receive immediate access to the intervention materials (the 10 brief Sleep Health Education Modules). The wait-list control group will receive access to intervention materials at 3 months post enrollment/baseline.
Within each agency, the investigators will recruit individual EMS clinicians to participate. Goal enrollment within each agency is a minimum of 30 and a maximum of 50 EMS clinicians.
All individual EMS clinician participants will undergo informed consent, answer a baseline survey, and be queried via mobile phone text message at regular intervals which will begin upon enrollment. These mobile phone text message queries will assess indicators of sleep and fatigue. All participants will be asked to answer two follow up surveys at 3 months and 6 months. The total duration of study participation is 6 months. The primary outcome of interest is sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcome of interest is fatigue as measured by the Chalder Fatigue Questionnaire (CFQ).
- Conditions
- Sleep Quality, Fatigue
- Being tested
- Sleep Health Education
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Health EducationOther
Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Health Education | Experimental | At baseline, the experimental group will have immediate access to 10 brief education modules focused on diverse elements of sleep health and fatigue. Receives: Other: Sleep Health Education |
| Wait List Control | Active comparator | At 3 months after baseline, the wait-list control group will be provided access to the 10 education modules focused on diverse elements of sleep health and fatigue.. Receives: Other: Sleep Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Sleep Quality at 3 Months
Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI) tool. Scores range from 0-21 with scores greater than or equal to 6 classified as poor sleep quality.
Measured: baseline to 3 months
Secondary outcomes (1)
Change From Baseline in Fatigue at 3 Months
Fatigue will be measured with the Chalder Fatigue Questionnaire (CFQ). The CFQ is a brief 11-item survey tool that measures mental and physical fatigue with scores ranging from 0-11. Scores 4 or greater indicate severe fatigue.
Measured: baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start24 Feb 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Why it stopped: Trial enrollment terminated early due to end of funding period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 678 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Highway Traffic Safety Administration (NHTSA), National Association of State EMS Officials
- Responsible party
- Principal investigator, Daniel Patterson, PhD, NRP, University of Pittsburgh
- Investigators
- Daniel Patterson, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218279
- Sponsor's protocol ID
- STUDY19080090
- Other IDs
- DTNH2215R00029
- Status last verified
- Apr 2022
- First submitted
- 2 Jan 2020
- Last updated
- 5 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual de-identified participant data collected during the trial will be shared with the funding organization (the National Highway Traffic Safety Administration (NHTSA)) and with researchers who provide a methodologically sound proposal and have been approved by the funding organization and by the University of Pittsburgh.
Publications
Patterson PD, Martin SE, MacAllister SA, Weaver MD, Patterson CG. Variations in Sleep, Fatigue, and Difficulty with Concentration Among Emergency Medical Services Clinicians During Shifts of Different Durations. Int J Environ Res Public Health. 2025 Apr 6;22(4):573. doi: 10.3390/ijerph22040573.
PubMed 40283798Patterson PD, Martin SE, Brassil BN, Hsiao WH, Weaver MD, Okerman TS, Seitz SN, Patterson CG, Robinson K. The Emergency Medical Services Sleep Health Study: A cluster-randomized trial. Sleep Health. 2023 Feb;9(1):64-76. doi: 10.1016/j.sleh.2022.09.013. Epub 2022 Nov 10.
PubMed 36372657
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EMS Sleep Health and Fatigue Study: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04218279
- Acronym / sponsor ID
- STUDY19080090
- Conditions
- Sleep Quality, Fatigue
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial enrollment terminated early due to end of funding period.
- Enrolment
- 678 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Highway Traffic Safety Administration (NHTSA), National Association of State EMS Officials
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Posted 5 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The experiment seeks to determine the impact of a sleep health and fatigue education and training program on diverse indicators of sleep and fatigue among Emergency Medical Services (EMS) personnel. The overarching goals of this research study are to [1] enhance our understanding of the relationships between shift work, sleep, and fatigue in EMS operations; and [2] determine whether or not providing education and training to EMS personnel on the importance of sleep health and dangers of fatigue impact indicators of sleep and fatigue. The investigators will accomplish these goals by using a cluster-randomized trial study design with a wait-list control group.
Detailed description
The overarching goals of this research study are to:
- enhance our understanding of the relationships between shift work, sleep, and fatigue in EMS operations; and
- determine whether or not providing education and training to EMS personnel on the importance of sleep health and dangers of fatigue impact indicators of sleep and fatigue.
The investigators will recruit EMS nationwide for EMS agencies to participate in this study and focus on moderately sized EMS agencies with between 50 and 300 employees (yet we will not outright exclude smaller or larger organizations). Agencies that run dual ground-based and air-medical EMS services are eligible. Maximum enrollment at the agency-level is n=30 EMS agencies. Agencies will be randomized upon enrollment to one of two arms: [1] Intervention group; or [2] the Wait-List control group. The intervention group will receive immediate access to the intervention materials (the 10 brief Sleep Health Education Modules). The wait-list control group will receive access to intervention materials at 3 months post enrollment/baseline.
Within each agency, the investigators will recruit individual EMS clinicians to participate. Goal enrollment within each agency is a minimum of 30 and a maximum of 50 EMS clinicians.
All individual EMS clinician participants will undergo informed consent, answer a baseline survey, and be queried via mobile phone text message at regular intervals which will begin upon enrollment. These mobile phone text message queries will assess indicators of sleep and fatigue. All participants will be asked to answer two follow up surveys at 3 months and 6 months. The total duration of study participation is 6 months. The primary outcome of interest is sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI). The secondary outcome of interest is fatigue as measured by the Chalder Fatigue Questionnaire (CFQ).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Health Education | Experimental | Other: Sleep Health EducationAt baseline, the experimental group will have immediate access to 10 brief education modules focused on diverse elements of sleep health and fatigue. |
| Wait List Control | Active comparator | Other: Sleep Health EducationAt 3 months after baseline, the wait-list control group will be provided access to the 10 education modules focused on diverse elements of sleep health and fatigue.. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- EMS Personnel:
Key exclusion criteria (8 listed)
- EMS Personnel:
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 EducationIntervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website. | Other | Sleep Health Education, Wait List Control |
Primary outcome
Change From Baseline in Sleep Quality at 3 Months
Time frame: baseline to 3 months
Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI) tool. Scores range from 0-21 with scores greater than or equal to 6 classified as poor sleep quality.
1 secondary outcome
Change From Baseline in Fatigue at 3 Months
Time frame: baseline to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40283798Patterson PD, Martin SE, MacAllister SA, Weaver MD, Patterson CG. Variations in Sleep, Fatigue, and Difficulty with Concentration Among Emergency Medical Services Clinicians During Shifts of Different Durations. Int J Environ Res Public Health. 2025 Apr 6;22(4):573. doi: 10.3390/ijerph22040573.
- Derived from this study: PubMed 36372657Patterson PD, Martin SE, Brassil BN, Hsiao WH, Weaver MD, Okerman TS, Seitz SN, Patterson CG, Robinson K. The Emergency Medical Services Sleep Health Study: A cluster-randomized trial. Sleep Health. 2023 Feb;9(1):64-76. doi: 10.1016/j.sleh.2022.09.013. Epub 2022 Nov 10.
- Individual participant dataSharing planned: Yes. All of the individual de-identified participant data collected during the trial will be shared with the funding organization (the National Highway Traffic Safety Administration (NHTSA)) and with researchers who provide a methodologically sound proposal and have been approved by the funding organization and by the University of Pittsburgh.
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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. This study is not recruiting at the moment.
Daniel Patterson principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Health Education in people with Sleep Quality and Fatigue, run by University of Pittsburgh at 1 site in United States.
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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 5 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Sleep Quality at 3 Months (time frame: baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04218279, which also lists 2 linked publications.
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 5 Apr 2022.