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Intra-Shift Napping for High Blood Pressure

N/A

Waitlist Available

Led By Leonard Weiss, MD

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 blood pressure will be monitored with automated devices at 1-hour intervals over 72 total hours

Awards & highlights

Study Summary

This trial will study the effects of taking naps on markers of cardiovascular disease risk in shift workers.

Eligible Conditions

High Blood Pressure
Heart Rate Variability

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ blood pressure will be monitored with automated devices at 1-hour intervals over 72 total hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~blood pressure will be monitored with automated devices at 1-hour intervals over 72 total hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and blood pressure will be monitored with automated devices at 1-hour intervals over 72 total hours for reporting.

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 with blunted dipping of blood pressure via the sleep based method

Number of participants with blunted dipping of blood pressure via the wide fixed time method

The number of participants with unhealthy Heart Rate Variability (HRV) measured via the standard deviation of the inter-beat intervals of normal sinus beats (SDNN)

Trial Design

6Treatment groups

Experimental Treatment

Group I: No nap, longer nap, then brief napExperimental Treatment1 Intervention

Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with no nap first, undergo a 1-week minimum washout, then complete the protocol again with a longer nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a brief nap opportunity.

Group II: No nap, brief nap, then longer napExperimental Treatment1 Intervention

Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with no nap first, undergo a 1-week minimum washout, then complete the protocol again with a brief nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a longer nap opportunity.

Group III: Longer nap, no nap, then brief napExperimental Treatment1 Intervention

Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with a longer nap first, undergo a 1-week minimum washout, then complete the protocol again with no nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a brief nap opportunity.

Group IV: Longer nap, brief nap, then no napExperimental Treatment1 Intervention

Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with a longer nap first, undergo a 1-week minimum washout, then complete the protocol again with a brief nap, then undergo a minimum 1-week washout, then return to complete the protocol again with no nap opportunity.

Group V: Brief nap, no nap, then longer napExperimental Treatment1 Intervention

Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with brief nap first, undergo a 1-week minimum washout, then complete the protocol again with no nap, then undergo a minimum 1-week washout, then return to complete the protocol again with a longer nap opportunity.

Group VI: Brief nap, longer nap, then no napExperimental Treatment1 Intervention

Participants will be monitored for 72 total hours, including a 12-hour simulated night shift. At baseline (consent), participants randomized to crossover study design with three study arms (No nap, brief nap, longer nap). In this sequence, participants will perform the 12-hour night shift with brief nap first, undergo a 1-week minimum washout, then complete the protocol again with longer nap, then undergo a minimum 1-week washout, then return to complete the protocol again with no nap opportunity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intra-Shift Napping

2021

N/A

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ZOLL FoundationUNKNOWN

1 Previous Clinical Trials

30 Total Patients Enrolled

University of PittsburghLead Sponsor

1,719 Previous Clinical Trials

16,342,313 Total Patients Enrolled

P. Daniel Patterson, PhDStudy DirectorUniversity of Pittsburgh

1 Previous Clinical Trials

708 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being admitted to join this clinical experiment?

"Affirmative. Clinicaltrials.gov data shows that this research study is actively recruiting participants, which was initially listed on March 1st 2021 and last updated on February 1st 2022. The trial requires 35 patients to be recruited from a single clinical site."

Answered by AI

For whom is this research initiative particularly suitable?

"This medical trial is seeking 35 individuals aged 18 or older with a healthy heart rate. To qualify, prospective participants must not have any history of hypertension, cardiovascular disease, myocardial infarction, stroke/TIA, chronic kidney disease, adrenal disease thyroid disease rheumatologic hematologic cancer dementia/memory loss organ transplantation insomnia sleep apnea or other breathing issues and they cannot be pregnant. Additionally they should hold active certification as an EMS clinician at the EMT-Basic Advanced Paramedic Flight Paramedic or Flight Nurse level."

Answered by AI

Is registration for this clinical trial still being accepted?

"Clinicaltrials.gov states that this trial, which began soliciting participants on March 1st 2021, is still open and actively recruiting patients. The most recent update to the study's information was made February 1st 2022."

Answered by AI