Extended Work Schedules, Sleep Loss and Health
EW and EWD
Extended Work Schedules and Health: Role of Sleep Loss
1 other identifier
interventional
49
1 country
1
Brief Summary
This study aims to determine whether abnormal bodily rhythms contribute to elevate the risk of diabetes, independently of the amount of sleep loss.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 1, 2009
CompletedFirst Posted
Study publicly available on registry
October 5, 2009
CompletedOctober 3, 2016
September 1, 2016
4.9 years
October 1, 2009
September 29, 2016
Conditions
Keywords
Study Arms (2)
Sleep loss and circadian alignment
EXPERIMENTALSleep restriction without circadian misalignment
Sleep loss and circadian misalignment
EXPERIMENTALInterventions
Sleep restricted to 5 hours per night for 8 nights
Sleep restricted to 5 h per day for 8 days, alternating night sleep and day sleep
Eligibility Criteria
You may qualify if:
- normal healthy men and women between the ages of 21 years and 39 years (inclusive) with normal weight (i.e., body mass index under 28 kg/m2 in men, 27 kg/m2 in women)
- normal findings on clinical examination, normal results on routine laboratory tests, normal EKG, normal glucose tolerance test, negative pregnancy test for women
- no personal history of psychiatric or endocrine illness
- no personal history of sleep disorder, usual total sleep time of at least 7 hours
- only female volunteers with normal ovulatory cycles will be included
You may not qualify if:
- subjects with irregular life habits (shiftworkers and subjects having traveled across time zones less than one month prior to the beginning of the baseline study)
- subjects taking any medication (including hormonal contraceptive therapy), and smokers are excluded
- subjects with significant sleep apnea (apnea index above 10) or significant arousal-associated periodic leg movements are excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Chicago
Chicago, Illinois, 60637, United States
Related Publications (2)
Leproult R, Holmback U, Van Cauter E. Circadian misalignment augments markers of insulin resistance and inflammation, independently of sleep loss. Diabetes. 2014 Jun;63(6):1860-9. doi: 10.2337/db13-1546. Epub 2014 Jan 23.
PMID: 24458353RESULTGrimaldi D, Carter JR, Van Cauter E, Leproult R. Adverse Impact of Sleep Restriction and Circadian Misalignment on Autonomic Function in Healthy Young Adults. Hypertension. 2016 Jul;68(1):243-50. doi: 10.1161/HYPERTENSIONAHA.115.06847. Epub 2016 Jun 6.
PMID: 27271308RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2009
First Posted
October 5, 2009
Study Start
January 1, 2003
Primary Completion
December 1, 2007
Study Completion
September 1, 2009
Last Updated
October 3, 2016
Record last verified: 2016-09