Brief on-shift nap for Endothelial Dysfunction

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Pittsburgh, Pittsburgh, PA
Endothelial Dysfunction+1 More
Brief on-shift nap - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Endothelial Dysfunction
  • Blood Pressures

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 20-30 minutes for each arm/condition

12 continuous hours for each arm/condition
Average blood pressure while awake during simulated night shift
20-30 minutes for each arm/condition
Average Reactive Hyperemia Index (RHI) after simulated night shift
Average Reactive Hyperemia Index (RHI) at baseline
45 minutes
Average blood pressure while napping during simulated night shift
48 continuous hours for each arm/condition
Number of Participants for which at least 70% of required Ambulatory BP readings were collected

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

The brief 45-minute nap, then no-nap
1 of 2
No-nap, then brief 45-minute nap
1 of 2
Experimental Treatment

15 Total Participants · 2 Treatment Groups

Primary Treatment: Brief on-shift nap · No Placebo Group · N/A

The brief 45-minute nap, then no-nap
Behavioral
Experimental Group · 1 Intervention: Brief on-shift nap · Intervention Types: Behavioral
No-nap, then brief 45-minute nap
Behavioral
Experimental Group · 1 Intervention: Brief on-shift nap · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 20-30 minutes for each arm/condition
Closest Location: University of Pittsburgh · Pittsburgh, PA
Photo of University of Pittsburgh Medical Center  1Photo of University of Pittsburgh Medical Center  2Photo of University of Pittsburgh Medical Center 3
2004First Recorded Clinical Trial
1 TrialsResearching Endothelial Dysfunction
647 CompletedClinical Trials

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,595 Previous Clinical Trials
6,284,567 Total Patients Enrolled
P. Daniel PattersonPrincipal InvestigatorUniversity of Pittsburgh

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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You are at least 18 years old.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.