NCT00272233

Brief 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. The purpose of this study is to determine the effects of sleep loss on blood hormone levels and blood vessel function in medical trainees.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2004

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
Last Updated

March 20, 2007

Status Verified

January 1, 2006

First QC Date

January 3, 2006

Last Update Submit

March 19, 2007

Conditions

Sleep Deprivation

Keywords

Inflammation Mediators [D23.469]Cardiovascular Physiologic Phenomena [G09.330.553]

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Medical resident in MICU rotation
  • Non-smoker
  • Body mass index \<28 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Stuart D Katz, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2006

First Posted

January 4, 2006

Study Start

December 1, 2004

Study Completion

June 1, 2005

Last Updated

March 20, 2007

Record last verified: 2006-01

Locations

US(1)