Immune Status After Being on Call for 24 Hrs

NCT06636318 | Recruiting DMC FDA Device

• 1 other identifier: IRB24-1426
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Deprivation

Outcome Measures

Primary Outcomes (1)

• Characterization of the phenotype and function of immune cells using flow cytometry

  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 Outcomes (3)

• Analyze the biometric data and correlate it with changes in sleep deprivation

  One week before rotation and the last week of rotation

• Analyze the biometric data and correlate it with changes in the immune response

  One week before rotation and the last week of rotation

• Analyze the biometric data and correlate it with changes in physical activity

  One week before rotation and the last week of rotation

Study Arms (1)

General Surgery Residents

General Surgery residents on during 24-hour rotation shifts

Diagnostic Test: Blood Sample Collection; Device: Actigraph (GT9X-BT) Monitor

Interventions

Blood Sample Collection DIAGNOSTIC_TEST

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.

General Surgery Residents

Actigraph (GT9X-BT) Monitor DEVICE

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.

General Surgery Residents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General Surgery residents, on during 24-hour shifts

You may qualify if:

• 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

You may not qualify if:

• Unwilling/unable to sign informed consent
• Vulnerable Subjects/Subject Capacity to provide consent

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Angelica Perez-Gutierrez, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelica Perez-Gutierrez, MD

CONTACT

773-834-5087; rperezgutierrez@bsd.uchicago.edu

Leila Yazdanbakhsh

CONTACT

leila.yazdanbakhsh@bsd.uchicago.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 10, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)