Sleep RestrictionPPGNCT00817700
Impact of a Sleep Debt in Middle-Aged and Older Adults
A study testing Sleep restriction in people with Sleep Restriction, run by University of Chicago at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Restriction
- What is being tested?
- Sleep restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal weight
- healthy
- age 18-75 old
Who cannot join
- sleep disorder
- irregular life habits (shift workers, travelers)
- smokers
- on medication
- consumption of > 2 alcohol or caffeinated beverages/day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sleep Restriction
- Being tested
- Sleep restriction
- Keywords
- Sleep, young adults, middle-age adults, older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep restrictionOther
Sleep restriction.
| Study group | Role | What they receive |
|---|---|---|
| Normal (8 hours) sleep time | No intervention | Subjects are studied under normal sleep time conditions. |
| Sleep restriction | Experimental | 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. Receives: Other: Sleep restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endocrine, metabolic, cardiovascular changes performance and autonomic nervous system activity before and after sleep restriction and after sleep recovery.
Measured: Completion of 23 day study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startApr 2005
- Primary completionNov 2007
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep RestrictionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eve Van Cauter, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817700
- Sponsor's protocol ID
- #13159A
- Other IDs
- 5P01AG011412
- Acronym
- PPG
- Status last verified
- Jan 2017
- First submitted
- 5 Jan 2009
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alteration of Sleep and Circadian Timing in Aging- Impact of a Sleep Debt in Middle-Aged and Older Adults
- ClinicalTrials.gov ID
- NCT00817700
- Acronym / sponsor ID
- PPG / #13159A
- Conditions
- Sleep Restriction
- Keywords
- Sleep, young adults, middle-age adults, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 6 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal (8 hours) sleep time | No intervention | –Subjects are studied under normal sleep time conditions. |
| Sleep restriction | Experimental | Other: Sleep restrictionSleep 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- normal weight
- healthy
- age 18-75 old
Key exclusion criteria (5 listed)
- sleep disorder
- irregular life habits (shift workers, travelers)
- smokers
- on medication
- consumption of > 2 alcohol or caffeinated beverages/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep restrictionSleep restriction. | Other | Sleep restriction |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
Related trials for Sleep Restriction
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Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)
Sleep Deprivation
Active, not recruitingEarly Phase 1
Sleep and Inflammatory Resolution Pathway
Inflammatory Response, Inflammation
Active, not recruiting
Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans
Prediabetes
Not yet recruiting
Time-Restricted Eating and Personalized Energy-Restricted Diet in Obese Postmenopausal Women
Obesity (BMI Equal to or >30), Postmenopausal Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eve Van Cauter, PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep restriction in people with Sleep Restriction, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.