Sleep DeprivationNCT00272233
Effects of Sleep Loss on Endothelial Function and Cytokine Levels in Internal Medicine Residents
An observational study of Sleep Deprivation, run by Yale University at 1 site in United States.
Trial summary
Work requirements for medical trainees result in substantial sleep loss. Sleep loss has been associated with increased levels of certain inflammatory hormones that could have negative impact on blood vessel function. 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
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Jun 2005
- 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
Who may be able to join
- Medical resident in MICU rotation
- Non-smoker
- Body mass index <28 kg/m2
Who cannot join
- Systolic blood pressure >140 mmHg; Diastolic blood pressure >90 mmHg
- Known history of diabetes mellitus, hypertension, hyperlipidemia
- Known history of acute or chronic inflammatory or infectious disease
- Known history of sleep disturbance unrelated to work
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06510
About this study
Work requirements for medical trainees result in substantial sleep loss. Sleep loss has been associated with increased levels of certain inflammatory hormones that could have negative impact on blood vessel function. The purpose of this study is to determine the effects of sleep loss on blood hormone levels and blood vessel function in medical trainees.
Read the detailed description
Context: Sleep loss is associated with increased blood levels of interleukin-6 (IL-6) and C-reactive protein (CRP). Medical residents are often deprived of normal sleep during extended work shifts, but the effects of work-related sleep loss on biomarkers of vascular inflammation and function are unknown.
Objective: We sought to test the hypothesis that sleep loss during extended work shifts during medical training is associated with increased circulating levels of pro-inflammatory biomarkers and evidence of vascular dysfunction.
Design: Outcome measures were assessed after extended 30-hour work shifts and non-extended 6-hour work shifts in a single-blind, randomized crossover design.
Setting: University hospital medical intensive care unit
Patients or Other Participants: Twenty-two healthy medical residents were studied during a medical intensive care unit rotation.
Main Outcome Measure(s): Sleep related cytokines (interleukin-6 and tumor necrosis factor), serum markers of vascular inflammation (C-reactive protein), and flow-mediated dilation in the brachial artery.
- Conditions
- Sleep Deprivation
- Keywords
- Inflammation Mediators [D23.469], Cardiovascular Physiologic Phenomena [G09.330.553]
- Medical subject headings
- Sleep Deprivation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startDec 2004
- Study completionJun 2005
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 Yale UniversityThe 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 22 participants
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Center for Research Resources (NCRR)
- Investigators
- Stuart D Katz, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272233
- Sponsor's protocol ID
- HIC26414
- Other IDs
- NIH NHLBI K24 04024
- Status last verified
- Jan 2006
- First submitted
- 3 Jan 2006
- Last updated
- 20 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Loss on Endothelial Function and Cytokine Levels in Internal Medicine Residents
- ClinicalTrials.gov ID
- NCT00272233
- Acronym / sponsor ID
- HIC26414
- Conditions
- Sleep Deprivation
- Keywords
- Inflammation Mediators [D23.469], Cardiovascular Physiologic Phenomena [G09.330.553]
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Center for Research Resources (NCRR)
- Study start
- Dec 2004
- Study completion
- Jun 2005
- First posted
- 4 Jan 2006 (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.
Work requirements for medical trainees result in substantial sleep loss. Sleep loss has been associated with increased levels of certain inflammatory hormones that could have negative impact on blood vessel function. The purpose of this study is to determine the effects of sleep loss on blood hormone levels and blood vessel function in medical trainees.
Detailed description
Context: Sleep loss is associated with increased blood levels of interleukin-6 (IL-6) and C-reactive protein (CRP). Medical residents are often deprived of normal sleep during extended work shifts, but the effects of work-related sleep loss on biomarkers of vascular inflammation and function are unknown.
Objective: We sought to test the hypothesis that sleep loss during extended work shifts during medical training is associated with increased circulating levels of pro-inflammatory biomarkers and evidence of vascular dysfunction.
Design: Outcome measures were assessed after extended 30-hour work shifts and non-extended 6-hour work shifts in a single-blind, randomized crossover design.
Setting: University hospital medical intensive care unit
Patients or Other Participants: Twenty-two healthy medical residents were studied during a medical intensive care unit rotation.
Main Outcome Measure(s): Sleep related cytokines (interleukin-6 and tumor necrosis factor), serum markers of vascular inflammation (C-reactive protein), and flow-mediated dilation in the brachial artery.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Medical resident in MICU rotation
- Non-smoker
- Body mass index <28 kg/m2
Key exclusion criteria (5 listed)
- Systolic blood pressure >140 mmHg; Diastolic blood pressure >90 mmHg
- Known history of diabetes mellitus, hypertension, hyperlipidemia
- Known history of acute or chronic inflammatory or infectious disease
- Known history of sleep disturbance unrelated to work
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2007.
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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.
Stuart D Katz, MD principal investigator
Yale University
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 Yale University at 1 site in United States.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 20 Mar 2007. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 20 Mar 2007.