- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07217769
- Original Trial
Effects of Operational Naps on Blood Pressure and Performance Among Night Shift Workers (EONN)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Daniel Patterson, PhD
- Phone Number: 412-647-3078
- Email: pdp3@pitt.edu
Study Contact Backup
- Name: Maureen Morgan
- Phone Number: 412-647-3078
- Email: mam84@pitt.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15261
- Recruiting
- University of Pittsburgh
-
Contact:
- Maureen Morgan
- Phone Number: 412-647-3078
- Email: mam84@pitt.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Napping order
5 x 4 x 3 x 2 = 120 possible orderings of the 5 interventions for each person.
|
No-nap opportunity offered
A 15-minute nap opportunity at 02:00am
A 30-minute nap opportunity at 02:00am
A 45-minute nap opportunity at 02:00am
A 60-minute nap opportunity at 02:00am
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During simulated night shift, 12 hours
|
|
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)
|
During simulated night shift, greater than or equal to 10 minutes post intervention nap
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance on simulated patient scenarios
Time Frame: During simulated night shift, 12 hours
|
Change in performance pre-to-post nap.
Performance rated from 0-100 with higher scores indicating better performance.
Positive change indicates improved performance.
|
During simulated night shift, 12 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel Patterson, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY25070009
- R61HL172984 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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