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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00817700
Other study ID # #13159A
Secondary ID 5P01AG011412
Status Completed
Phase N/A
First received January 5, 2009
Last updated January 9, 2017
Start date April 2005
Est. completion date May 2008

Study information

Verified date January 2017
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 project has 6 aims.

1. To examine the impact of recurrent partial sleep loss in young, middle-aged and older men and women. Sleep will be restricted to 4 hours.

2. To test the hypothesis that extending bedtimes to allow for sleep recovery will reverse the metabolic, endocrine, and cardiovascular and neuro-behavioral alterations resulting from sleep restriction. Sleep will be extended to 12 hours following the 4 hour sleep restriction.

3. To test the hypothesis that there are age and gender differences in the total amount of sleep recovery obtained during the week of 12-hour bedtimes.

4. To test the hypothesis that there are age and gender differences in sleep capacity (the amount of time an individual can sleep per night when there is no sleep debt).

5. To test the hypothesis that sleep capacity is partly determined by baseline levels of slow-wave sleep and slow-wave activity.

6. To determine whether sleep capacity is related to sleep need by examining metabolic, endocrine, cardiovascular and neuro-behavioral changes with the amount of the individual sleep debt.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date May 2008
Est. primary completion date November 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- normal weight

- healthy

- age 18-75 old

Exclusion Criteria:

- sleep disorder

- irregular life habits (shift workers, travelers)

- smokers

- on medication

- consumption of > 2 alcohol or caffeinated beverages/day

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Sleep restriction
Sleep restriction.

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, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endocrine, metabolic, cardiovascular changes performance and autonomic nervous system activity before and after sleep restriction and after sleep recovery. Completion of 23 day study No
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