Effect of Partial Sleep Deprivation on Immunological System in Peripheral Blood

Sleep Deprivation Clinical Trial

Official title:

Effect of Sleep Deprivation on Expression of T Cell Markers in Peripheral Blood of Medical Residents

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01930279
• Other study ID #: LDB001
• Status: Not yet recruiting
• Phase: N/A
• First received: August 25, 2013
• Last updated: August 27, 2013
• Start date: September 2013
• Est. completion date: September 2014

Study information

• Verified date: August 2013
• Source: Hadassah Medical Organization
• Contact: Ayman Abu rmeileh, MD
• Phone: 0584400010
• Email: aymansar[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionIsrael: Ministry of HealthIsrael: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Other:
• Blood withdrawal
Blood withdrawal

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surface markers of T cell as assessed by FACS		6 months	Yes
Primary	serum cytokine levels		6 months	Yes
Primary	immune parameters to be assessed by western including STAT proteins		6 months	Yes