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On-Shift Napping for Endothelial Dysfunction
N/A
Waitlist Available
Led By P. Daniel Patterson
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20-30 minutes for each arm/condition
Awards & highlights
Study Summary
This trial is testing whether it's feasible to collect blood pressure readings from night shift workers. They need 10 participants to consider it a success.
Who is the study for?
This study is for adults over 18 who work night shifts, especially in public safety or healthcare in Western Pennsylvania. They must be EMTs, paramedics, nurses, physicians, or similar professionals without a history of serious health conditions like heart disease or cancer.Check my eligibility
What is being tested?
The trial is testing the effects of taking brief naps during night shifts on cardiovascular health indicators such as blood pressure. It aims to see if enough data can be collected from participants during simulated night shift work.See study design
What are the potential side effects?
Since the intervention involves only brief on-shift napping and monitoring blood pressure, there are no direct side effects expected from this activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20-30 minutes for each arm/condition
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20-30 minutes for each arm/condition
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants for which at least 70% of required Ambulatory BP readings were collected
Secondary outcome measures
Average Reactive Hyperemia Index (RHI) after simulated night shift
Average Reactive Hyperemia Index (RHI) at baseline
Average blood pressure while awake during simulated night shift
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: The brief 45-minute nap, then no-napExperimental Treatment1 Intervention
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
Group II: No-nap, then brief 45-minute napExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brief on-shift nap
2022
N/A
~10
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,731 Previous Clinical Trials
16,307,427 Total Patients Enrolled
P. Daniel PattersonPrincipal InvestigatorUniversity of Pittsburgh
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with any of the following: high blood pressure, heart disease, heart attack, stroke, kidney disease, liver disease, adrenal disease, thyroid disease, rheumatologic disease, blood disorder, any type of cancer, memory loss or dementia, organ transplantation, significant sleep problem, excessive alcohol consumption, sleep apnea, or any other condition that affects breathing or the airway.
Research Study Groups:
This trial has the following groups:- Group 1: The brief 45-minute nap, then no-nap
- Group 2: No-nap, then brief 45-minute nap
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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