Effect of Partial Sleep Deprivation on Immunological System in Peripheral Blood

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
ayman abu rmaileh, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01930279
First received: August 25, 2013
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Sleep Deprivation
Other: Blood withdrawal

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Sleep Deprivation on Expression of T Cell Markers in Peripheral Blood of Medical Residents

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • surface markers of T cell as assessed by FACS [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • serum cytokine levels [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • immune parameters to be assessed by western including STAT proteins [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
surface markers on T cells as assessed by FACS Other: Blood withdrawal
Blood withdrawal

Detailed Description:

Overall Study Design and Plan

  1. Subjects will be bled on the day of the experiment between 8and 9 AM.
  2. Blood tubes will be tested for T cell markers, serum cytokines levels, and other immune parameters by western blots.
  3. The first tube will be tested on the day of experiment.
  4. The second tube will kept in the lab and will be tested 24 hours later.
  5. The third tube will be kept in the pocket of the subject and be tested 24 hours later.
  6. The fourth tube will be kept in the pocket of another subject and will be tested 24 hours later.
  7. The subject will be tested again following 24 hours.
  8. 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.
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Medical residnets

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930279

Contacts
Contact: Ayman Abu rmeileh, MD 0584400010 ext 00972 aymansar@gmail.com
Contact: Tawfik Khoury, MD 0509870611 ext 00972 taufick@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Contact: Ayman Abu Rmeileh, MD    0584400010 ext 00972    aymansar@gmail.com   
Contact: Tawfik Khoury, MD    0509870611 ext 00972    taufick@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: ayman abu rmaileh, MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01930279     History of Changes
Other Study ID Numbers: LDB001
Study First Received: August 25, 2013
Last Updated: August 27, 2013
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health
Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Hadassah Medical Organization:
T cell markers

Additional relevant MeSH terms:
Sleep Deprivation
Dyssomnias
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Sleep Disorders

ClinicalTrials.gov processed this record on October 21, 2014