Night Shift Work, On-shift Napping, and Endothelial Function: A Pilot Study

NCT05436951 | Completed

• 1 other identifier: STUDY22040156
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease (CVD) and CVD risk factors such as high blood pressure (BP) are disproportionately higher among night shift workers, including those who work in public safety and healthcare. The purpose of this pilot study is to assess feasibility of collecting data germane to key indicators of cardiovascular health (i.e., ambulatory blood pressure) repeatedly during a simulated night shift protocol. The primary outcome measure will be the number of participants for which at least 70% of required ambulatory BP measures were collected. A result of at least 10 participants/subjects will be considered feasible.

Conditions

Blood Pressure; Endothelial Dysfunction

Keywords

Ambulatory Blood Pressure; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Number of Participants for which at least 70% of required Ambulatory BP readings were collected

  A result of at least 10 participants will be considered feasible

  48 continuous hours for each arm/condition

Secondary Outcomes (4)

• Average blood pressure while awake during simulated night shift

  12 continuous hours for each arm/condition

• Average blood pressure while napping during simulated night shift

  45 minutes

• Average Reactive Hyperemia Index (RHI) at baseline

  20-30 minutes for each arm/condition

• Average Reactive Hyperemia Index (RHI) after simulated night shift

  20-30 minutes for each arm/condition

Study Arms (2)

No-nap, then brief 45-minute nap

EXPERIMENTAL

Participants will be monitored for a total of 48 hours, including a 12-hour simulated night shift. At baseline (consent), participants are randomized to a crossover study design with two study arms (no nap, brief 45-minute nap). In this sequence, participants will perform the 12-hour simulated night shift with no nap first, undergo a minimum of 1-week washout, then return complete the 48-hour protocol again with the brief 45-minute nap.

Behavioral: Brief on-shift nap

The brief 45-minute nap, then no-nap

EXPERIMENTAL

Participants will be monitored for a total of 48 hours, including a 12-hour simulated night shift. At baseline (consent), participants are randomized to a crossover study design with two study arms (no nap, brief 45-minute nap). In this sequence, participants will perform the 12-hour simulated night shift with the brief 45-minute nap, undergo a 1-week minimum washout, then return to complete the 48-hour protocol again with the no-nap

Behavioral: Brief on-shift nap

Interventions

Brief on-shift nap BEHAVIORAL

The brief nap opportunity will allow for a 45-minute nap between the hours of 0200 and 0300 during the in-lab 12-hour simulated night shift.

No-nap, then brief 45-minute nap; The brief 45-minute nap, then no-nap

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants will be working aged adults (18 years of age or older). Investigators are interested in enrolling public safety workers and healthcare workers given how often this group works night shifts.
• Criteria that participants will need to address:
• years of age or older;
• Currently licensed or certified as an EMS clinician, other public safety shift worker, or other type of healthcare clinicians and actively working in Western Pennsylvania as an EMT, Paramedic, Flight Nurse/Paramedic, other EMS clinician, firefighter, or other type of healthcare clinician (e.g., nurse, physician, physician assistants, patient care technician, or other healthcare clinician);

You may not qualify if:

• Having ever been diagnosed with the following: hypertension, cardiovascular disease, myocardial infarction, stroke/TIA, chronic kidney disease, liver disease, adrenal disease, thyroid disease, rheumatologic disease, hematologic disease, cancer of any type, dementia/memory loss, organ transplantation; major sleep problem; heavy alcohol use; sleep apnea or other diagnosis that is related to problems with breathing or the airway;
• Current pregnancy;

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

• Patterson PD, Hilditch CJ, Martin SE, Roach DGL, Weaver MD, Okerman TS, Hostler D, Weiss LS, Reis SE. Comparison of 45-min nap versus no-nap during simulated night shift work on endothelial function: a randomized crossover feasibility trial. Pilot Feasibility Stud. 2024 Nov 12;10(1):137. doi: 10.1186/s40814-024-01569-2.

  PMID: 39533414 DERIVED

Study Officials

• P. Daniel Patterson

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized crossover study design

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: June 28, 2022
• Primary Completion: March 4, 2023
• Study Completion: March 4, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)