- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01930279
Effect of Partial Sleep Deprivation on Immunological System in Peripheral Blood
Effect of Sleep Deprivation on Expression of T Cell Markers in Peripheral Blood of Medical Residents
Sleep deprivation was found to affect many organs including the immune system and predisposing for various health consequences including diabetes hypertension infections and increase in neoplastic diseases.
Subjects will be evaluated for immune parameters in peripheral blood test following a regular nigh sleep and compared with a test performed following a night shift in which they slept less than 3 hours.
Each participant will serve as its own control.
Study Overview
Detailed Description
Overall Study Design and Plan
- Subjects will be bled on the day of the experiment between 8and 9 AM.
- Blood tubes will be tested for T cell markers, serum cytokines levels, and other immune parameters by western blots.
- The first tube will be tested on the day of experiment.
- The second tube will kept in the lab and will be tested 24 hours later.
- The third tube will be kept in the pocket of the subject and be tested 24 hours later.
- The fourth tube will be kept in the pocket of another subject and will be tested 24 hours later.
- The subject will be tested again following 24 hours.
- Each subject will be tested twice following a regular 6-8 hours of sleep, and following an on call duty in which he slept less than 3 hours.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Jerusalem, Israel, 91120
- Hadassah Medical Organization
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Male and female ages 18-40 signed confirmed consent no evidence of chronic disease or chronic medications
Exclusion Criteria:
Any type of acute infection or other acute illness
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
surface markers on T cells as assessed by FACS
|
Blood withdrawal
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
surface markers of T cell as assessed by FACS
Time Frame: 6 months
|
6 months
|
|
serum cytokine levels
Time Frame: 6 months
|
6 months
|
|
immune parameters to be assessed by western including STAT proteins
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LDB001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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