Effects of Chronic Sleep Restriction in Young and Older People
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | April 27, 2007 | ||||
| Last Updated Date | April 28, 2009 | ||||
| Start Date ICMJE | December 2006 | ||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00506428 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Chronic Sleep Restriction in Young and Older People | ||||
| Official Title ICMJE | Sleep, Aging, and Circadian Rhythm Disorders | ||||
| Brief Summary | The purpose of this study is to examine the consequences of chronic sleep restriction on nighttime sleep, daytime alertness, performance and memory functions, and metabolic and cardiovascular function, and to determine if the consequences of chronic sleep restriction differ between healthy young and older adults. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: Open Label |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: chronic sleep restriction
5.6 hours of sleep per 24 hours for 3 weeks |
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| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 25 | ||||
| Estimated Completion Date | June 2011 | ||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00506428 | ||||
| Other Study ID Numbers ICMJE | AG0077, 2P01AG009975-11 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Charles A Czeisler, PhD, MD, Brigham & Women's Hospital | ||||
| Study Sponsor ICMJE | National Institute on Aging (NIA) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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