Extended Work Schedules, Sleep Loss and Health

NCT ID: NCT00989534

Last Updated: 2016-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2009-09-30

Brief Summary

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

Detailed Description

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Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Sleep loss and circadian alignment

Sleep restriction without circadian misalignment

Group Type EXPERIMENTAL

Fixed restricted bedtimes

Intervention Type BEHAVIORAL

Sleep restricted to 5 hours per night for 8 nights

Sleep loss and circadian misalignment

Group Type EXPERIMENTAL

Sleep restriction with circadian misalignment

Intervention Type BEHAVIORAL

Sleep restricted to 5 h per day for 8 days, alternating night sleep and day sleep

Interventions

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Fixed restricted bedtimes

Sleep restricted to 5 hours per night for 8 nights

Intervention Type BEHAVIORAL

Sleep restriction with circadian misalignment

Sleep restricted to 5 h per day for 8 days, alternating night sleep and day sleep

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 24458353 (View on PubMed)

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.

Reference Type RESULT
PMID: 27271308 (View on PubMed)

Other Identifiers

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11403A

Identifier Type: -

Identifier Source: org_study_id

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