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NCT Number: NCT06636318

Immune Status After Being on Call for 24 Hrs

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Angelica Perez-Gutierrez, MD

CONTACT

[email protected]

773-834-5087

Leila Yazdanbakhsh

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Impact of a 24-hour Shift Call on the Immune Status of Surgery Residents

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 10, 2024
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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