Shift WorkEONNNCT07217769
Effects of Operational Naps on Blood Pressure and Performance Among Night Shift Workers
A study testing No-nap, 15-min nap and 30-min nap in people with Shift Work, run by University of Pittsburgh at 1 site in United States.
Trial summary
Night shift work schedules disrupt sleep and have a negative impact on cardiovascular health. Most who work in public safety occupations and in healthcare work night shifts. These workers experience abnormal blood pressure during night shifts and are at greater risk of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shift Work
- What is being tested?
- No-nap, 15-min nap and 30-min nap
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2026to 31 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- non-pregnant adults (>18 years of age)
- certified public safety/healthcare shift worker
- is an active shift worker
- resides within the Western Pennsylvania region within reasonable driving distance
Who cannot join
- current use of medication for cardiovascular disease (e.g., hypertension)
- prior or current diagnosis of sleep apnea, narcolepsy, restless leg syndrome, ischemic heart disease, heart failure, stroke, chronic kidney disease, chronic liver disease, rheumatologic disease requiring prescription medication, and cancer requiring treatment in past 2 years
- undiagnosed severe sleep apnea (Apnea-Hypopnea Index >30) based on at-home test
- Abstains from caffeine or reports adverse effects from caffeine use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Maureen Morgan, 412-647-3078, mam84@pitt.edu
About this study
Night shift work schedules disrupt sleep and have a negative impact on cardiovascular health. Most who work in public safety occupations and in healthcare work night shifts. These workers experience abnormal blood pressure during night shifts and are at greater risk of cardiovascular disease. Napping during night shifts can help to restore blood pressure patterns to a more normal pattern and may help to reduce risk of cardiovascular disease. Naps may also have an impact on alertness and performance immediately upon waking. The overarching goal of this study is to determine which duration of a nap taken during simulated night shift work has the greatest impact blood pressure and post-nap performance.
Researchers will compare 5 nap durations to see which has the greatest impact on blood pressure patterns and post-nap psychomotor performance.
Read more
Researchers hypothesize that longer naps will lead to improved blood pressure outcomes and shorter naps will contribute to better performance after waking.
Findings will help employers and employees who work night shifts determine how best to incorporate brief naps during night shift work.
Read the detailed description
Blunted blood pressure (BP) dipping is a well-described risk factor for cardiovascular disease (CVD) among older adults and individuals with chronic disease. Previous research shows that night shift workers are at risk and repeatedly exposed to blunted BP dipping as a consequence of sleep loss and irregular sleep. While occasional episodes of blunted BP dipping may not be harmful, repetitive exposure over years of night shift work, as experienced by public safety workers (PSWs) and healthcare workers (HCWs), is likely detrimental to cardiovascular health and increases risk of CVD. Recent research shows that exposure can be mitigated with brief on-duty naps, which briefly restore normal BP dipping. Despite these data, there is legitimate clinical equipoise regarding the optimal on-duty nap duration (dose) needed to maximize BP dipping and minimize threats to post-nap psychomotor performance (i.e., sleep inertia).
This study will use a Phase II, within subject, crossover, incomplete block randomized trial design to test the efficacy of 5 overnight on-duty nap conditions: no-nap, 15, 30, 45, and 60-minutes. The primary outcome is the proportion of participants with a clinically meaningful greater than or equal to 10% dip in BP during nap opportunities. The secondary outcome is focused on deficits in psychomotor performance at greater than or equal to 10 mins post-nap: a safety-critical moment for PSWs and HCWs.
Goal enrollment is set at 130, accounting for attrition. Each condition begins with 36 hours of at-home monitoring with non-invasive devices. The last 12 hours of each condition includes a 12-hour simulated night shift with nap opportunities provided at 0200 hours with the nap duration determined by the randomization schema. During the simulated night shift, participants will be continuously monitored with non-invasive devices, allowed to consume controlled amounts of caffeine, and complete standardized tests of psychomotor performance. Participants will be blinded to nap duration and caffeine dose. Volunteer participants will be asked to complete 4 of the 5 nap conditions.
- Conditions
- Shift Work
- Being tested
- No-nap, 15-min nap, 30-min nap, 45-min nap, 60-min nap
- Keywords
- Night shift, Sleep, Napping, Blood pressure, Psychomotor performance, Sleep inertia, Caffeine
- Medical subject headings
- Idiopathic Hypersomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No-napBehavioural
No-nap opportunity offered
15-min napBehavioural
A 15-minute nap opportunity at 02:00am
30-min napBehavioural
A 30-minute nap opportunity at 02:00am
45-min napBehavioural
A 45-minute nap opportunity at 02:00am
60-min napBehavioural
A 60-minute nap opportunity at 02:00am
| Study group | Role | What they receive |
|---|---|---|
| Napping order | Other | 5 x 4 x 3 x 2 = 120 possible orderings of the 5 interventions for each person. Receives: Behavioral: No-nap; Behavioral: 15-min nap; Behavioral: 30-min nap; Behavioral: 45-min nap; Behavioral: 60-min nap |
What is being measured
The primary outcome is the main question the study is designed to answer.
BP dipping
The ratio of mean sleep to mean wake blood pressure (BP) by taking the difference between the mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) during nap opportunities, and the mean SBP and DBP during wake periods.
Measured: During simulated night shift, 12 hours
Psychomotor performance post-nap
Severe psychomotor impairment post-nap as measured by the Psychomotor Vigilance Test Brief (PVT-B)
Measured: During simulated night shift, greater than or equal to 10 minutes post intervention nap
Secondary outcomes (1)
Performance on simulated patient scenarios
Change in performance pre-to-post nap. Performance rated from 0-100 with higher scores indicating better performance. Positive change indicates improved performance.
Measured: During simulated night shift, 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start7 May 2026
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shift WorkStudies 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
- Crossover
- Model description
- This study uses an incomplete block design with participants completing 4 of the 5 conditions in random order.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- 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
- NCT07217769
- Sponsor's protocol ID
- STUDY25070009
- Other IDs
- R61HL172984
- Acronym
- EONN
- Status last verified
- Jun 2026
- First submitted
- 2 Oct 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Operational Naps on Blood Pressure and Performance Among Night Shift Workers
- ClinicalTrials.gov ID
- NCT07217769
- Acronym / sponsor ID
- EONN / STUDY25070009
- Conditions
- Shift Work
- Keywords
- Night shift, Sleep, Napping, Blood pressure, Psychomotor performance, Sleep inertia, Caffeine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 May 2026 (actual)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 16 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Night shift work schedules disrupt sleep and have a negative impact on cardiovascular health. Most who work in public safety occupations and in healthcare work night shifts. These workers experience abnormal blood pressure during night shifts and are at greater risk of cardiovascular disease. Napping during night shifts can help to restore blood pressure patterns to a more normal pattern and may help to reduce risk of cardiovascular disease. Naps may also have an impact on alertness and performance immediately upon waking. The overarching goal of this study is to determine which duration of a nap taken during simulated night shift work has the greatest impact blood pressure and post-nap performance.
Researchers will compare 5 nap durations to see which has the greatest impact on blood pressure patterns and post-nap psychomotor performance.
Researchers hypothesize that longer naps will lead to improved blood pressure outcomes and shorter naps will contribute to better performance after waking.
Findings will help employers and employees who work night shifts determine how best to incorporate brief naps during night shift work.
Detailed description
Blunted blood pressure (BP) dipping is a well-described risk factor for cardiovascular disease (CVD) among older adults and individuals with chronic disease. Previous research shows that night shift workers are at risk and repeatedly exposed to blunted BP dipping as a consequence of sleep loss and irregular sleep. While occasional episodes of blunted BP dipping may not be harmful, repetitive exposure over years of night shift work, as experienced by public safety workers (PSWs) and healthcare workers (HCWs), is likely detrimental to cardiovascular health and increases risk of CVD. Recent research shows that exposure can be mitigated with brief on-duty naps, which briefly restore normal BP dipping. Despite these data, there is legitimate clinical equipoise regarding the optimal on-duty nap duration (dose) needed to maximize BP dipping and minimize threats to post-nap psychomotor performance (i.e., sleep inertia).
This study will use a Phase II, within subject, crossover, incomplete block randomized trial design to test the efficacy of 5 overnight on-duty nap conditions: no-nap, 15, 30, 45, and 60-minutes. The primary outcome is the proportion of participants with a clinically meaningful greater than or equal to 10% dip in BP during nap opportunities. The secondary outcome is focused on deficits in psychomotor performance at greater than or equal to 10 mins post-nap: a safety-critical moment for PSWs and HCWs.
Goal enrollment is set at 130, accounting for attrition. Each condition begins with 36 hours of at-home monitoring with non-invasive devices. The last 12 hours of each condition includes a 12-hour simulated night shift with nap opportunities provided at 0200 hours with the nap duration determined by the randomization schema. During the simulated night shift, participants will be continuously monitored with non-invasive devices, allowed to consume controlled amounts of caffeine, and complete standardized tests of psychomotor performance. Participants will be blinded to nap duration and caffeine dose. Volunteer participants will be asked to complete 4 of the 5 nap conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses an incomplete block design with participants completing 4 of the 5 conditions in random order.
| Arm | Type | Receives |
|---|---|---|
| Napping order | Other | Behavioral: No-nap, Behavioral: 15-min nap, Behavioral: 30-min nap, Behavioral: 45-min nap, Behavioral: 60-min nap5 x 4 x 3 x 2 = 120 possible orderings of the 5 interventions for each person. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- non-pregnant adults (>18 years of age)
- certified public safety/healthcare shift worker
- is an active shift worker
- resides within the Western Pennsylvania region within reasonable driving distance
Key exclusion criteria (4 listed)
- current use of medication for cardiovascular disease (e.g., hypertension)
- prior or current diagnosis of sleep apnea, narcolepsy, restless leg syndrome, ischemic heart disease, heart failure, stroke, chronic kidney disease, chronic liver disease, rheumatologic disease requiring prescription medication, and cancer requiring treatment in past 2 years
- undiagnosed severe sleep apnea (Apnea-Hypopnea Index >30) based on at-home test
- Abstains from caffeine or reports adverse effects from caffeine use
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 |
|---|---|---|
| No-napNo-nap opportunity offered | Behavioural | Napping order |
| 15-min napA 15-minute nap opportunity at 02:00am | Behavioural | Napping order |
| 30-min napA 30-minute nap opportunity at 02:00am | Behavioural | Napping order |
| 45-min napA 45-minute nap opportunity at 02:00am | Behavioural | Napping order |
| 60-min napA 60-minute nap opportunity at 02:00am | Behavioural | Napping order |
Primary outcome
BP dipping
Time frame: During simulated night shift, 12 hours
The ratio of mean sleep to mean wake blood pressure (BP) by taking the difference between the mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) during nap opportunities, and the mean SBP and DBP during wake periods.
Psychomotor performance post-nap
Time frame: During simulated night shift, greater than or equal to 10 minutes post intervention nap
Severe psychomotor impairment post-nap as measured by the Psychomotor Vigilance Test Brief (PVT-B)
1 secondary outcome
Performance on simulated patient scenarios
Time frame: During simulated night shift, 12 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected IPD
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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.
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 No-nap, 15-min nap and 30-min nap in people with Shift Work, 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Patterson, PhD (412-647-3078, pdp3@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BP dipping (time frame: During simulated night shift, 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2026.