Effects of Operational Naps on Blood Pressure and Performance Among Night Shift Workers

NCT07217769 | Recruiting DMC

• 2 other identifiers: STUDY25070009R61HL172984
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Shift Work

Keywords

Night shift; Sleep; Napping; Blood pressure; Psychomotor performance; Sleep inertia; Caffeine

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  During simulated night shift, greater than or equal to 10 minutes post intervention nap

Secondary Outcomes (1)

• Performance on simulated patient scenarios

  During simulated night shift, 12 hours

Study Arms (1)

Napping order

OTHER

5 x 4 x 3 x 2 = 120 possible orderings of the 5 interventions for each person.

Behavioral: No-nap; Behavioral: 15-min nap; Behavioral: 30-min nap; Behavioral: 45-min nap; Behavioral: 60-min nap

Interventions

No-nap BEHAVIORAL

No-nap opportunity offered

Napping order

15-min nap BEHAVIORAL

A 15-minute nap opportunity at 02:00am

Napping order

30-min nap BEHAVIORAL

A 30-minute nap opportunity at 02:00am

Napping order

45-min nap BEHAVIORAL

A 45-minute nap opportunity at 02:00am

Napping order

60-min nap BEHAVIORAL

A 60-minute nap opportunity at 02:00am

Napping order

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

RECRUITING

MeSH Terms

Conditions

Idiopathic Hypersomnia

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Daniel Patterson

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Patterson, PhD

CONTACT

412-647-3078; pdp3@pitt.edu

Maureen Morgan

CONTACT

412-647-3078; mam84@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants are blinded to the nap duration.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study uses an incomplete block design with participants completing 4 of the 5 conditions in random order.

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 16, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2030
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: No later than 3 years after completing the last follow-up of the last participant.
• Access Criteria: Access through NHLBI BioLINCC repository

Locations

US (1)