Extended Work Schedules, Sleep Loss and Health

Sleep Clinical Trial

— EW and EWD  

Official title:

Extended Work Schedules and Health: Role of Sleep Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989534
• Other study ID #: 11403A
• Status: Completed
• Phase: N/A
• First received: October 1, 2009
• Last updated: September 29, 2016
• Start date: January 2003
• Est. completion date: September 2009

Study information

• Verified date: September 2016
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study aims to determine whether abnormal bodily rhythms contribute to elevate the risk of diabetes, independently of the amount of sleep loss.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2009
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 39 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Sleep

Intervention

Behavioral:
• Fixed restricted bedtimes
Sleep restricted to 5 hours per night for 8 nights
• Sleep restriction with circadian misalignment
Sleep restricted to 5 h per day for 8 days, alternating night sleep and day sleep

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (2)

Grimaldi 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. — View Citation

Leproult R, Holmbäck 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. — View Citation