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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05436951
• Other study ID #: STUDY22040156
• Status: Completed
• Phase: N/A
• Start date: June 28, 2022
• Est. completion date: March 4, 2023

Study information

• Verified date: January 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. Risk of CVD events such as myocardial infarction and stroke are higher among shift workers than non-shift workers. Risk of atrial fibrillation is 1.22 times greater (95%CI 1.02, 1.45) among individuals that work 3-to-8 night shifts per month versus non-shift workers. A comprehensive explanation for why shift workers, especially night shift workers, are at greater risk of CVD is not yet available. However, some research suggests that night shift workers experience repeated exposure to sleep deprivation, which impacts normal patterns in BP and endothelial function. Endothelial dysfunction and disruption of normal BP patterns are independently linked to numerous indicators of CVD, including cardiac-related mortality.

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. Investigators propose a laboratory-based pilot study whereby participants (volunteers) complete two conditions. Condition one will include a 12-hour simulated night shift in our lab with no napping. Condition two will involve a 12-hour simulated night shift in our lab with a 45 minute nap at 0200 hours. Participants will be asked to wear monitoring devices for approximately 48 total hours with the last 12 hours of monitoring (from 1900 to 0700) to be in our lab.

Aim 1: Assess the feasibility of collecting ambulatory BP measures (ABPM) and indicators of endothelial function at multiple time points prior to, during, and after simulated night shift work.

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.

Aim 2: Characterize the impact of simulated night shift work and on-shift napping on BP dipping and endothelial function.

Secondary endpoints include quantifying descriptive statistics (e.g., means and standard deviations) for BP dipping and endothelial function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 4, 2023
• Est. primary completion date: March 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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:

1. 18 years of age or older;

2. 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);

3. a 'no' answer to #2 above is not a criterion for exclusion.

Exclusion Criteria:

1. 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;

2. Current pregnancy;

3. Insomnia is NOT a criterion for exclusion.

Related Conditions & MeSH terms

• Blood Pressure
• Endothelial Dysfunction

Intervention

Behavioral:
• Brief on-shift nap
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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Average blood pressure while awake during simulated night shift	The mean and standard deviation of blood pressure measurements taken while participant is awake during the 12-hour simulated night shift	12 continuous hours for each arm/condition
Secondary	Average blood pressure while napping during simulated night shift	The mean and standard deviation of blood pressure measurements taken while participant is napping (sleeping) during the 12-hour simulated night shift that includes the 45-minute nap condition.	45 minutes
Secondary	Average Reactive Hyperemia Index (RHI) at baseline	The mean and standard deviation RHI score for the endothelial dysfunction measurement assessed at baseline	20-30 minutes for each arm/condition
Secondary	Average Reactive Hyperemia Index (RHI) after simulated night shift	The mean and standard deviation RHI score for the endothelial dysfunction measurement assessed after the 12-hour simulated night shift	20-30 minutes for each arm/condition