University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
NCT Number: NCT05436951
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.
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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15261, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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:
Exclusion criteria
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.
Time frame: 48 continuous hours for each arm/condition
A result of at least 10 participants will be considered feasible
Time frame: 12 continuous hours for each arm/condition
The mean and standard deviation of blood pressure measurements taken while participant is awake during the 12-hour simulated night shift
Time frame: 45 minutes
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.
Time frame: 20-30 minutes for each arm/condition
The mean and standard deviation RHI score for the endothelial dysfunction measurement assessed at baseline
Time frame: 20-30 minutes for each arm/condition
The mean and standard deviation RHI score for the endothelial dysfunction measurement assessed after the 12-hour simulated night shift
University of Pittsburgh
Other
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