Effect of Partial Sleep Deprivation on Immunological Syst... | NCT01930279

Studies
Effect of Partial Sleep Deprivation on Immunological System in Peripheral Blood

NCT01930279

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Aug 28, 2013Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Sleep Deprivation

Interventions

Blood withdrawal

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Sep 2014Estimated

Completion Date

Sep 2014Estimated

First Submitted Date

Aug 25, 2013

First Submission Date that Met QC Criteria

Aug 27, 2013

First Posted Date

Aug 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2013

Last Update Posted Date

Aug 28, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

ayman abu rmaileh, MD, Hadassah Medical OrganizationPrincipal Investigator

Lead Sponsor

Hadassah Medical OrganizationOTHER

Collaborators

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
surface markers on T cells as assessed by FACS			Other: Blood withdrawal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood withdrawal	Other	Blood withdrawal	surface markers on T cells as assessed by FACS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
surface markers of T cell as assessed by FACS		6 months
serum cytokine levels		6 months
immune parameters to be assessed by western including STAT proteins		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Medical residnets

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ayman Abu rmeileh, MD	Contact	0584400010	00972	aymansar@gmail.com
Tawfik Khoury, MD	Contact	0509870611	00972	taufick@hadassah.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem	Jerusalem	91120	Israel

Condition Browse Module

MeSH Terms

ID	Term
D012892	Sleep Deprivation

Ancestor Terms

ID	Term
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided