Effects of Operational Naps on Blood Pressure and Performance Among Night Shift Workers
NCT ID: NCT07217769
Last Updated: 2025-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
130 participants
INTERVENTIONAL
2026-06-01
2030-08-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Napping order
5 x 4 x 3 x 2 = 120 possible orderings of the 5 interventions for each person.
No-nap
No-nap opportunity offered
15-min nap
A 15-minute nap opportunity at 02:00am
30-min nap
A 30-minute nap opportunity at 02:00am
45-min nap
A 45-minute nap opportunity at 02:00am
60-min nap
A 60-minute nap opportunity at 02:00am
Interventions
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No-nap
No-nap opportunity offered
15-min nap
A 15-minute nap opportunity at 02:00am
30-min nap
A 30-minute nap opportunity at 02:00am
45-min nap
A 45-minute nap opportunity at 02:00am
60-min nap
A 60-minute nap opportunity at 02:00am
Eligibility Criteria
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Inclusion Criteria
* certified public safety/healthcare shift worker
* is an active shift worker
* resides within the Western Pennsylvania region within reasonable driving distance
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Daniel Patterson, PhD, NRP
Professor
Principal Investigators
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Daniel Patterson
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY25070009
Identifier Type: -
Identifier Source: org_study_id
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