Sleep DeprivationNCT01930279
Effect of Partial Sleep Deprivation on Immunological System in Peripheral Blood
An observational study of Sleep Deprivation, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Blood withdrawal
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2013to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Medical residnets
Who may be able to join
- Male and female ages 18-40 signed confirmed consent no evidence of chronic disease or chronic medications
Who cannot join
- Any type of acute infection or other acute illness
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem, Jerusalem, 91120
Ayman Abu Rmeileh, MD, 0584400010 ext. 00972, aymansar@gmail.com
Tawfik Khoury, MD, 0509870611 ext. 00972, taufick@hadassah.org.il
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Deprivation
- Being tested
- Blood withdrawal
- Keywords
- T cell markers
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood withdrawalOther
Blood withdrawal
| Study group | Role | What they receive |
|---|---|---|
| surface markers on T cells as assessed by FACS | Not described Receives: Other: Blood withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
surface markers of T cell as assessed by FACS
Measured: 6 months
serum cytokine levels
Measured: 6 months
immune parameters to be assessed by western including STAT proteins
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DeprivationStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ayman abu rmaileh, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930279
- Sponsor's protocol ID
- LDB001
- Status last verified
- Aug 2013
- First submitted
- 25 Aug 2013
- Last updated
- 28 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sleep Deprivation on Expression of T Cell Markers in Peripheral Blood of Medical Residents
- ClinicalTrials.gov ID
- NCT01930279
- Acronym / sponsor ID
- LDB001
- Conditions
- Sleep Deprivation
- Keywords
- T cell markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surface markers on T cells as assessed by FACS | – | Other: Blood withdrawal |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Medical residnets
Key inclusion criteria (1 listed)
- Male and female ages 18-40 signed confirmed consent no evidence of chronic disease or chronic medications
Key exclusion criteria (1 listed)
- Any type of acute infection or other acute illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood withdrawalBlood withdrawal | Other | surface markers on T cells as assessed by FACS |
Primary outcome
surface markers of T cell as assessed by FACS
Time frame: 6 months
serum cytokine levels
Time frame: 6 months
immune parameters to be assessed by western including STAT proteins
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
Related trials for Sleep Deprivation
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
Recruiting
The Function of Biphasic Sleep in Infants
Sleep Deprivation
Not yet recruiting
Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Sleep Deprivation
Recruiting
Sleep and Circadian Rhythm Intervention in ICU
ICU Hospitalization, Circadian Rhythm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Deprivation, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayman Abu rmeileh, MD (0584400010 ext. 00972, aymansar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surface markers of T cell as assessed by FACS (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2013.