- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00817700
Impact of a Sleep Debt in Middle-Aged and Older Adults (PPG)
January 9, 2017 updated by: University of Chicago
Alteration of Sleep and Circadian Timing in Aging- Impact of a Sleep Debt in Middle-Aged and Older Adults
This project has 6 aims.
- 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.
- 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.
- 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.
- 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).
- To test the hypothesis that sleep capacity is partly determined by baseline levels of slow-wave sleep and slow-wave activity.
- 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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- The University of Chicago
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Normal (8 hours) sleep time
Subjects are studied under normal sleep time conditions.
|
|
Experimental: Sleep restriction
Sleep 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. |
Sleep restriction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Endocrine, metabolic, cardiovascular changes performance and autonomic nervous system activity before and after sleep restriction and after sleep recovery.
Time Frame: Completion of 23 day study
|
Completion of 23 day study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eve Van Cauter, PhD, University of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
January 5, 2009
First Submitted That Met QC Criteria
January 5, 2009
First Posted (Estimate)
January 6, 2009
Study Record Updates
Last Update Posted (Estimate)
January 11, 2017
Last Update Submitted That Met QC Criteria
January 9, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #13159A
- 5P01AG011412 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep Restriction
-
Shanghai Jiao Tong University School of MedicineCompletedSleep RestrictionChina
-
United States Army Research Institute of Environmental...CompletedSleep RestrictionUnited States
-
University of GlasgowRecruitingSleep Restriction | Normal SleepUnited Kingdom
-
Lundquist Institute for Biomedical Innovation at...Active, not recruitingSleep RestrictionUnited States
-
Walter Reed Army Institute of Research (WRAIR)National Institute of Mental Health (NIMH); National Intrepid Center of ExcellenceRecruiting
-
Lundquist Institute for Biomedical Innovation at...Active, not recruiting
-
Christian BaumannSwiss Federal Institute of Technology in Zurich (ETH Zurich)Completed
-
Pennington Biomedical Research CenterUnited States Department of Defense; University of Arkansas; United States Army...CompletedSleep | Exercise | Caloric RestrictionUnited States
-
University School of Physical Education, Krakow...Enrolling by invitationSleep | Sleep RestrictionPoland
-
University of PennsylvaniaCompletedSleep Restriction Then Total Sleep Deprivation | Total Sleep Deprivation Then Sleep RestrictionUnited States
Clinical Trials on Sleep restriction
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São Paulo; Associação Fundo de Incentivo...Completed
-
Lance BollingerNational Aeronautics and Space Administration (NASA)RecruitingMuscle Weakness | Sleep Disturbance | Quadriceps Muscle AtrophyUnited States
-
Esther WerthCompletedIdiopathic Hypersomnia | Narcolepsy 1Switzerland
-
University of ZurichFonds für Verkehrssicherheit FVSCompletedSleep Deprivation | Sleepiness | Insufficient Sleep SyndromeSwitzerland
-
University School of Physical Education, Krakow...Jagiellonian UniversityRecruitingSleep | Sleep RestrictionPoland
-
Oregon Health and Science UniversityRecruitingObesity | Glucose Intolerance | Sleep Deprivation | Weight Gain | Food SelectionUnited States
-
University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruiting
-
Institut de Recherche Biomedicale des ArmeesCompleted
-
Region StockholmRecruiting
-
Mayo ClinicNational Heart, Lung, and Blood Institute (NHLBI)Completed