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Sleep Loss for Arterial Stiffness

N/A
Recruiting
Led By 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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up total sleep duration (in minutes) during the entire protocol (over 97 hours).
Awards & highlights

Study Summary

This trial will look at how night shift work affects arterial stiffness, which can lead to health issues.

Who is the study for?
This trial is for healthy individuals aged 20-29 who can commit to a strict 4-day protocol without interruptions. They must not have cardiovascular health issues, take medications affecting blood pressure or heart rate, use tobacco products, or consume caffeine and exercise during the study period. Pregnant individuals or those with conditions like sleep apnea, night terrors, or anger issues upon waking are excluded.Check my eligibility
What is being tested?
The study aims to understand how acute sleep loss similar to that experienced by night shift workers affects arterial stiffness. It involves mimicking a night shift schedule and measuring changes in Pulse Wave Velocity (PWV), which indicates arterial stiffness.See study design
What are the potential side effects?
Since this trial focuses on the effects of sleep loss rather than medication side effects per se, participants may experience tiredness, irritability, difficulty concentrating and potential short-term increases in blood pressure due to lack of sleep.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~total sleep duration (in minutes) during the entire protocol (over 97 hours).
This trial's timeline: 3 weeks for screening, Varies for treatment, and total sleep duration (in minutes) during the entire protocol (over 97 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
Changes in pulse wave velocity (PWV) in response to 24 hours of acute sleep loss
Changes in pulse wave velocity (PWV) in response to 48 hours of acute sleep loss
Circadian changes in pulse wave velocity (PWV)
Other outcome measures
Cognitive performance at 48 hours of acute sleep loss
Cognitive performance first 24 hours of acute sleep loss
Fatigue at 48 hours of acute sleep loss
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sleep LossExperimental Treatment1 Intervention
Participants will undergo a night shift work like schedule and be monitored with non-invasive devices while at-home (at set intervals) and during an in-lab phase (hourly) during a 97 continuous-hour protocol. During the in-lab phase, which is approximately 48 continuous hours, participants will undergo a 24-hour period of sleep loss, followed by a brief opportunity for an in-lab sleep opportunity of 5 hours, followed by another period of 19 hours of sleep loss before returning home for at-home monitoring. Measures of interest include arterial stiffness as measured by pulse wave velocity (PWV) and changes in subjective ratings (e.g., fatigue and sleepiness). Other measures include cognitive performance, total sleep during the protocol, and sleep depth during an in-lab sleep opportunity.

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Who is running the clinical trial?

University of PittsburghLead Sponsor
1,723 Previous Clinical Trials
16,343,149 Total Patients Enrolled
Daniel PattersonPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
678 Total Patients Enrolled

Media Library

Arterial Stiffness Clinical Trial 2023: Sleep Loss Highlights & Side Effects. Trial Name: NCT05940467 — N/A

Frequently Asked Questions

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

Am I eligible to join the research initiative?

"To participate in this clinical investigation, individuals must possess arterial stiffness and be aged between 20-29. A maximum of 7 participants can join the trial."

Answered by AI

Does the age criteria for this trial extend beyond 60 years of age?

"This trial has specified that only those aged 20 to 29 are eligible for participation. There is a seperate study available for minors and 6 other clinical trials designed specifically cater to the over 65 demographic."

Answered by AI

Are individuals with relevant conditions still eligible to partake in this trial?

"As reflected in clinicaltrials.gov's records, this trial has ceased recruiting participants as of July 4th 2023. Despite the closure, there are still 10 other medical studies seeking enrolment at present."

Answered by AI
~2 spots leftby Aug 2024