- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00506428
Effects of Chronic Sleep Restriction in Young and Older People
Sleep, Aging, and Circadian Rhythm Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It has long been recognized that sleep patterns change with age. A common feature of aging is the advance of the timing of sleep to earlier hours, often earlier than desired. Polysomnographically-recorded sleep in older people shows an increased number of awakenings, a reduction of stages 3 and 4 (SWS) sleep, and a flattening of REM sleep distribution throughout the night. These age-related changes are found in even healthy individuals who are not taking medications and who are free from sleep disorders. In addition to these sleep disturbances, many older individuals curtail their sleep voluntarily, reporting similar rates of sleep restriction (sleeping less than 7 or less than 6 hours per night) as young adults. Whether voluntary or not, insufficient sleep has medical, safety and metabolic consequences. In fact, converging evidence in young adults suggests that sleep restriction per se may impair metabolism, and that reduced sleep duration is associated with weight gain, obesity, diabetes, cardiovascular disease, and mortality.
The study begins with 21 days of outpatient study in which the participants will be required to sleep for 10 hours each night in order to ensure they are well-rested. This will be followed by a 39-day inpatient study. The study will begin with 3 "sleep satiation" days during which all participants will be scheduled to sleep for 12 hours per night and have a 4 hour nap each afternoon. This is followed by 3 baseline days in which the participants will follow the same sleep-wake schedule they were following at home. Following this, the participant will undergo 3 weeks of chronic sleep restriction while living on a non-24-hour schedule. The participant will live on a schedule that is equivalent to 5.6 hours of sleep per 24 hours. Following these 3 weeks, the participant will be scheduled to again sleep for 10 hours per night for 10 nights.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Brigham & Women's Hospital
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Contact:
- Tomoko Okada
- Phone Number: 617-732-7991
- Email: sleepstudy@partners.org
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Contact:
- Sean W Cain, PhD
- Phone Number: 617-732-5174
- Email: swcain@rics.bwh.harvard.edu
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Principal Investigator:
- Charles A Czeisler, PhD, MD
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Sub-Investigator:
- Jeanne F Duffy, PhD
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Sub-Investigator:
- Sean W Cain, PhD
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Sub-Investigator:
- Mirjam Munch, PhD
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Sub-Investigator:
- Daniel Aeschbach, PhD
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Sub-Investigator:
- Elizabeth B Klerman, MD, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy
Exclusion Criteria:
- Chronic or acute medical condition
- Medication use
- Depression
- History of psychiatric illness
- Sleep disorder
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in sleep and waking EEG measures
Time Frame: During 3-week chronic sleep restriction segment of inpatient study
|
During 3-week chronic sleep restriction segment of inpatient study
|
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frequent measures of performance, attention, alertness, and memory
Time Frame: During 3-week chronic sleep restriction segment of inpatient study
|
During 3-week chronic sleep restriction segment of inpatient study
|
|
measures of cardiovascular and metabolic function
Time Frame: During 3-week chronic sleep restriction segment of inpatient study
|
During 3-week chronic sleep restriction segment of inpatient study
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Dijk DJ, Duffy JF, Czeisler CA. Circadian and sleep/wake dependent aspects of subjective alertness and cognitive performance. J Sleep Res. 1992 Jun;1(2):112-7. doi: 10.1111/j.1365-2869.1992.tb00021.x.
- Boivin DB, Czeisler CA, Dijk DJ, Duffy JF, Folkard S, Minors DS, Totterdell P, Waterhouse JM. Complex interaction of the sleep-wake cycle and circadian phase modulates mood in healthy subjects. Arch Gen Psychiatry. 1997 Feb;54(2):145-52. doi: 10.1001/archpsyc.1997.01830140055010.
- Klerman EB, Davis JB, Duffy JF, Dijk DJ, Kronauer RE. Older people awaken more frequently but fall back asleep at the same rate as younger people. Sleep. 2004 Jun 15;27(4):793-8. doi: 10.1093/sleep/27.4.793.
- Dijk DJ, Duffy JF, Czeisler CA. Age-related increase in awakenings: impaired consolidation of nonREM sleep at all circadian phases. Sleep. 2001 Aug 1;24(5):565-77. doi: 10.1093/sleep/24.5.565.
- Dijk DJ, Duffy JF, Czeisler CA. Contribution of circadian physiology and sleep homeostasis to age-related changes in human sleep. Chronobiol Int. 2000 May;17(3):285-311. doi: 10.1081/cbi-100101049.
- Dijk DJ, Duffy JF, Riel E, Shanahan TL, Czeisler CA. Ageing and the circadian and homeostatic regulation of human sleep during forced desynchrony of rest, melatonin and temperature rhythms. J Physiol. 1999 Apr 15;516 ( Pt 2)(Pt 2):611-27. doi: 10.1111/j.1469-7793.1999.0611v.x.
- Czeisler CA, Duffy JF, Shanahan TL, Brown EN, Mitchell JF, Rimmer DW, Ronda JM, Silva EJ, Allan JS, Emens JS, Dijk DJ, Kronauer RE. Stability, precision, and near-24-hour period of the human circadian pacemaker. Science. 1999 Jun 25;284(5423):2177-81. doi: 10.1126/science.284.5423.2177.
- Dijk DJ, Shanahan TL, Duffy JF, Ronda JM, Czeisler CA. Variation of electroencephalographic activity during non-rapid eye movement and rapid eye movement sleep with phase of circadian melatonin rhythm in humans. J Physiol. 1997 Dec 15;505 ( Pt 3)(Pt 3):851-8. doi: 10.1111/j.1469-7793.1997.851ba.x.
- Duffy JF. Increased sleep disruption, reduced sleepiness in older subjects? Sleep. 2005 Nov;28(11):1358-9. No abstract available.
- Duffy JF, Czeisler CA. Age-related change in the relationship between circadian period, circadian phase, and diurnal preference in humans. Neurosci Lett. 2002 Feb 1;318(3):117-20. doi: 10.1016/s0304-3940(01)02427-2.
- Pavlova MK, Duffy JF, Shea SA. Polysomnographic respiratory abnormalities in asymptomatic individuals. Sleep. 2008 Feb;31(2):241-8. doi: 10.1093/sleep/31.2.241.
- Silva EJ, Duffy JF. Sleep inertia varies with circadian phase and sleep stage in older adults. Behav Neurosci. 2008 Aug;122(4):928-35. doi: 10.1037/0735-7044.122.4.928.
- Munch MY, Cain SW, Duffy JF. Biological Rhythms Workshop IC: sleep and rhythms. Cold Spring Harb Symp Quant Biol. 2007;72:35-46. doi: 10.1101/sqb.2007.72.065.
- Swanson CM, Shea SA, Kohrt WM, Wright KP, Cain SW, Munch M, Vujovic N, Czeisler CA, Orwoll ES, Buxton OM. Sleep Restriction With Circadian Disruption Negatively Alter Bone Turnover Markers in Women. J Clin Endocrinol Metab. 2020 Jul 1;105(7):2456-63. doi: 10.1210/clinem/dgaa232.
- Swanson CM, Shea SA, Wolfe P, Cain SW, Munch M, Vujovic N, Czeisler CA, Buxton OM, Orwoll ES. Bone Turnover Markers After Sleep Restriction and Circadian Disruption: A Mechanism for Sleep-Related Bone Loss in Humans. J Clin Endocrinol Metab. 2017 Oct 1;102(10):3722-3730. doi: 10.1210/jc.2017-01147.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AG0077
- 2P01AG009975-11 (U.S. NIH Grant/Contract)
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