Clinical trial NCT05436951: Night Shift Work, On-shift Napping, and Endothelial Function: A Pilot Study
Official title: Night Shift Work, On-shift Napping, and Endothelial Function: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Endothelial Dysfunction
Keywords: Ambulatory Blood Pressure
Endothelial Dysfunction
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover study design
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants for which at least 70% of required Ambulatory BP readings were collected
timeFrame: 48 continuous hours for each arm/condition
Secondary outcomes:
measure: Average blood pressure while awake during simulated night shift
timeFrame: 12 continuous hours for each arm/condition
measure: Average blood pressure while napping during simulated night shift
timeFrame: 45 minutes
measure: Average Reactive Hyperemia Index (RHI) at baseline
timeFrame: 20-30 minutes for each arm/condition
measure: Average Reactive Hyperemia Index (RHI) after simulated night shift
timeFrame: 20-30 minutes for each arm/condition
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: P. Daniel Patterson
role: PRINCIPAL_INVESTIGATOR
References: