Immune Status After Being on Call for 24 Hrs

Recruiting

• Conditions: Sleep Deprivation
• Interventions: Diagnostic Test: Blood Sample Collection; Device: Actigraph (GT9X-BT) Monitor

• Registration Number: NCT06636318
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-27
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-10
• Study Start: 2024-10-17
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
General Surgery Residents	Blood Sample Collection	General Surgery residents on during 24-hour rotation shifts
General Surgery Residents	Actigraph (GT9X-BT) Monitor	General Surgery residents on during 24-hour rotation shifts

Primary Outcome Measures

Name	Time	Method
Characterization of the phenotype and function of immune cells using flow cytometry	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.

Secondary Outcome Measures

Name	Time	Method
Analyze the biometric data and correlate it with changes in sleep deprivation	One week before rotation and the last week of rotation	To examine the associations, participants will be using an activity and sleep monitor.
Analyze the biometric data and correlate it with changes in the immune response	One week before rotation and the last week of rotation	To examine the associations, participants will be using an activity and sleep monitor.
Analyze the biometric data and correlate it with changes in physical activity	One week before rotation and the last week of rotation	To examine the associations, participants will be using an activity and sleep monitor.

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States