- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06636318
Immune Status After Being on Call for 24 Hrs
Impact of a 24-hour Shift Call on the Immune Status of Surgery Residents
Sleep deprivation is a prevalent problem in modern societies. Sleep deprivation can cause hormonal changes, such as an increase in cortisol, as well as inflammation. Animal studies have shown an increase in inflammatory cytokine production following sleep deprivation. Additionally, humans experiencing sleep deprivation may experience a decrease in natural killer cells and lymphocytes.
Physicians, particularly those in surgical specialties, are often subjected to sleep deprivation as part of their medical residency training. This study hypothesizes that after 24-hour shifts, there is an increase in inflammatory response and impairment of the immune response against unspecific activation. This proposal aims to provide insight into the impact of sleep deprivation on the immune system of surgery residents by characterizing the phenotype and function of immune cells, as well as their correlation with biometric data.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Angelica Perez-Gutierrez, MD
- Phone Number: 773-834-5087
- Email: rperezgutierrez@bsd.uchicago.edu
Study Contact Backup
- Name: Leila Yazdanbakhsh
- Email: leila.yazdanbakhsh@bsd.uchicago.edu
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60637
- Recruiting
- The University of Chicago
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Contact:
- Leila Yazdanbakhsh
- Phone Number: 773-834-5087
- Email: leila.yazdanbakhsh@bsd.uchicago.edu
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Contact:
- Shalitha Johnson
- Phone Number: 773-834-8758
- Email: sjohnson28@bsd.uchicago.edu
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Principal Investigator:
- Angelica Perez-Gutierrez, MD
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy subjects
- Surgery residents in a 24-hour shift rotation
- Gender of subjects: Males and females
- Age of subjects: 18 years old and older
- Racial and Ethnic Origin: Any race or ethnicity
Exclusion Criteria:
- Unwilling/unable to sign informed consent
- Vulnerable Subjects/Subject Capacity to provide consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
General Surgery Residents
General Surgery residents on during 24-hour rotation shifts
|
To characterize the phenotype and function of immune cells in surgery residents before and after a 24-hour shift, and before and after a month of being "on call".
Along with to investigate the relationship between sleep deprivation, physical activity, and different immune responses.
Participants will be asked to wear their monitor every day for a week.
The monitor will collect their step count, sleep and heart rate automatically.
Participants will return their monitor at visit 5 (day 30) of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Characterization of the phenotype and function of immune cells using flow cytometry
Time Frame: 24 hours
|
Specifically, T cells, B cells, dendritic cells, macrophages, and natural killer cells will be identified and analyzed.
Memory cells, co-inhibitor markers, and regulatory markers will also be evaluated.
The function will be analyzed based on the intracellular expression of effector molecules and cytokines after unspecific activation with CD3-CD28 beads.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analyze the biometric data and correlate it with changes in sleep deprivation
Time Frame: One week before rotation and the last week of rotation
|
To examine the associations, participants will be using an activity and sleep monitor.
|
One week before rotation and the last week of rotation
|
|
Analyze the biometric data and correlate it with changes in the immune response
Time Frame: One week before rotation and the last week of rotation
|
To examine the associations, participants will be using an activity and sleep monitor.
|
One week before rotation and the last week of rotation
|
|
Analyze the biometric data and correlate it with changes in physical activity
Time Frame: One week before rotation and the last week of rotation
|
To examine the associations, participants will be using an activity and sleep monitor.
|
One week before rotation and the last week of rotation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Angelica Perez-Gutierrez, MD, University of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB24-1426
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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