Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT06636318
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2024-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immune Status After Being on Call for 24 Hrs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012892', 'term': 'Sleep Deprivation'}], 'ancestors': [{'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2024-09-27', 'studyFirstSubmitQcDate': '2024-10-09', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterization of the phenotype and function of immune cells using flow cytometry', 'timeFrame': '24 hours', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Analyze the biometric data and correlate it with changes in sleep deprivation', 'timeFrame': 'One week before rotation and the last week of rotation', 'description': 'To examine the associations, participants will be using an activity and sleep monitor.'}, {'measure': 'Analyze the biometric data and correlate it with changes in the immune response', 'timeFrame': 'One week before rotation and the last week of rotation', 'description': 'To examine the associations, participants will be using an activity and sleep monitor.'}, {'measure': 'Analyze the biometric data and correlate it with changes in physical activity', 'timeFrame': 'One week before rotation and the last week of rotation', 'description': 'To examine the associations, participants will be using an activity and sleep monitor.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sleep Deprivation']}, 'descriptionModule': {'briefSummary': '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.\n\nPhysicians, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'General Surgery residents, on during 24-hour shifts', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects\n* Surgery residents in a 24-hour shift rotation\n* Gender of subjects: Males and females\n* Age of subjects: 18 years old and older\n* Racial and Ethnic Origin: Any race or ethnicity\n\nExclusion Criteria:\n\n* Unwilling/unable to sign informed consent\n* Vulnerable Subjects/Subject Capacity to provide consent'}, 'identificationModule': {'nctId': 'NCT06636318', 'briefTitle': 'Immune Status After Being on Call for 24 Hrs', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Impact of a 24-hour Shift Call on the Immune Status of Surgery Residents', 'orgStudyIdInfo': {'id': 'IRB24-1426'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General Surgery Residents', 'description': 'General Surgery residents on during 24-hour rotation shifts', 'interventionNames': ['Diagnostic Test: Blood Sample Collection', 'Device: Actigraph (GT9X-BT) Monitor']}], 'interventions': [{'name': 'Blood Sample Collection', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['General Surgery Residents']}, {'name': 'Actigraph (GT9X-BT) Monitor', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['General Surgery Residents']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shalitha Johnson', 'role': 'CONTACT', 'email': 'sjohnson28@bsd.uchicago.edu', 'phone': '773-834-8758'}, {'name': 'Leila Yazdanbakhsh', 'role': 'CONTACT', 'email': 'leila.yazdanbakhsh@bsd.uchicago.edu', 'phone': '773-834-5087'}, {'name': 'Angelica Perez-Gutierrez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Angelica Perez-Gutierrez, MD', 'role': 'CONTACT', 'email': 'rperezgutierrez@bsd.uchicago.edu', 'phone': '773-834-5087'}, {'name': 'Leila Yazdanbakhsh', 'role': 'CONTACT', 'email': 'leila.yazdanbakhsh@bsd.uchicago.edu'}], 'overallOfficials': [{'name': 'Angelica Perez-Gutierrez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}