Sleep DeprivationNCT06636318
Immune Status After Being on Call for 24 Hrs
An observational study of Sleep Deprivation, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Blood Sample Collection and Actigraph (GT9X-BT) Monitor
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General Surgery residents, on during 24-hour shifts
Who may be able to join
- 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
Who cannot join
- Unwilling/unable to sign informed consent
- Vulnerable Subjects/Subject Capacity to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Leila Yazdanbakhsh contact
United States1 site, 1 recruiting
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
Shalitha Johnson, 773-834-8758, sjohnson28@bsd.uchicago.edu
Leila Yazdanbakhsh, 773-834-5087, leila.yazdanbakhsh@bsd.uchicago.edu
About this study
Official title: 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.
- Conditions
- Sleep Deprivation
- Being tested
- Blood Sample Collection, Actigraph (GT9X-BT) Monitor
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample CollectionDiagnostic 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) MonitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| General Surgery Residents | General Surgery residents on during 24-hour rotation shifts Receives: Diagnostic Test: Blood Sample Collection; Device: Actigraph (GT9X-BT) Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (3)
Analyze the biometric data and correlate it with changes in sleep deprivation
To examine the associations, participants will be using an activity and sleep monitor.
Measured: One week before rotation and the last week of rotation
Analyze the biometric data and correlate it with changes in the immune response
To examine the associations, participants will be using an activity and sleep monitor.
Measured: One week before rotation and the last week of rotation
Analyze the biometric data and correlate it with changes in physical activity
To examine the associations, participants will be using an activity and sleep monitor.
Measured: One week before rotation and the last week of rotation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start17 Oct 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angelica Perez-Gutierrez, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636318
- Sponsor's protocol ID
- IRB24-1426
- Status last verified
- Dec 2025
- First submitted
- 27 Sep 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a 24-hour Shift Call on the Immune Status of Surgery Residents
- ClinicalTrials.gov ID
- NCT06636318
- Acronym / sponsor ID
- IRB24-1426
- Conditions
- Sleep Deprivation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General Surgery Residents | – | Diagnostic Test: Blood Sample Collection, Device: Actigraph (GT9X-BT) MonitorGeneral Surgery residents on during 24-hour rotation shifts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General Surgery residents, on during 24-hour shifts
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Unwilling/unable to sign informed consent
- Vulnerable Subjects/Subject Capacity to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sample CollectionTo 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. | Diagnostic test | General Surgery Residents |
| Actigraph (GT9X-BT) MonitorParticipants 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. | Device | General Surgery Residents |
Primary outcome
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.
3 secondary outcomes
Analyze the biometric data and correlate it with changes in sleep deprivation
Time frame: 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
Analyze the biometric data and correlate it with changes in physical activity
Time frame: One week before rotation and the last week of rotation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leila Yazdanbakhsh contact
Angelica Perez-Gutierrez, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Deprivation, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angelica Perez-Gutierrez, MD (773-834-5087, rperezgutierrez@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the phenotype and function of immune cells using flow cytometry (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.