Impact of a Sleep Debt in Middle-Aged and Older Adults
PPG
Alteration of Sleep and Circadian Timing in Aging- Impact of a Sleep Debt in Middle-Aged and Older Adults
2 other identifiers
interventional
72
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2005
Typical duration 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
April 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 5, 2009
CompletedFirst Posted
Study publicly available on registry
January 6, 2009
CompletedJanuary 11, 2017
January 1, 2017
2.6 years
January 5, 2009
January 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endocrine, metabolic, cardiovascular changes performance and autonomic nervous system activity before and after sleep restriction and after sleep recovery.
Completion of 23 day study
Study Arms (2)
Normal (8 hours) sleep time
NO INTERVENTIONSubjects are studied under normal sleep time conditions.
Sleep restriction
EXPERIMENTALSleep restriction to 4 hours of sleep per night. Overnight sleep recording, measures of endocrine and metabolic (from blood), cardiovascular (measures of blood pressure and heart rate), performance ( before and after sleep restriction and after sleep recovery.
Interventions
Eligibility Criteria
You may qualify if:
- normal weight
- healthy
- age 18-75 old
You may not qualify if:
- sleep disorder
- irregular life habits (shift workers, travelers)
- smokers
- on medication
- consumption of \> 2 alcohol or caffeinated beverages/day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Chicago
Chicago, Illinois, 60637, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Eve Van Cauter, PhD
University of Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2009
First Posted
January 6, 2009
Study Start
April 1, 2005
Primary Completion
November 1, 2007
Study Completion
May 1, 2008
Last Updated
January 11, 2017
Record last verified: 2017-01