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AgingNCT00506428

Effects of Chronic Sleep Restriction in Young and Older People

A study testing chronic sleep restriction in people with Aging and Sleep Deprivation, run by National Institute on Aging (NIA) at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Aging, Sleep Deprivation, Metabolic Syndrome
What is being tested?
chronic sleep restriction
How many people
25 participants
Where
1 siteUnited States
Study dates
Dec 2006to Jun 2011
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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy

Who cannot join

  • Chronic or acute medical condition
  • Medication use
  • Depression
  • History of psychiatric illness
  • Sleep disorder

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

    Tomoko Okada, 617-732-7991, sleepstudy@partners.org

    Sean W Cain, PhD, 617-732-5174, swcain@rics.bwh.harvard.edu

    Recruiting

Other trials in United States

About this study

Official title: Sleep, Aging, and Circadian Rhythm Disorders

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.

Read the 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.

Being tested
chronic sleep restriction
Keywords
aging, sleep, sleep deprivation, performance, memory, metabolism
Medical subject headings
Sleep Deprivation, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chronic sleep restrictionBehavioural

    5.6 hours of sleep per 24 hours for 3 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in sleep and waking EEG measures

    Measured: During 3-week chronic sleep restriction segment of inpatient study

  2. frequent measures of performance, attention, alertness, and memory

    Measured: During 3-week chronic sleep restriction segment of inpatient study

  3. measures of cardiovascular and metabolic function

    Measured: During 3-week chronic sleep restriction segment of inpatient study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionJun 2011 (estimated)
  4. Study completionJun 2011 (estimated)

Resources

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
Crossover
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00506428
Sponsor's protocol ID
AG0077
Other IDs
2P01AG009975-11
Status last verified
Apr 2009
First submitted
27 Apr 2007
Last updated
29 Apr 2009
Results posted
No
Data monitoring committee
No

Publications

  • Czeisler CA, Duffy JF, Shanahan TL, Brown EN, Mitchell JF, Rimmer DW, Ronda JM, Silva EJ, Allan JS, Emens JS, Dijk DJ, Kronauer RE; New Collective Author. 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.

    PubMed 10381883

  • 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.

    PubMed 10087357

  • 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.

    PubMed 9457658

  • 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.

    PubMed 9040282

  • 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.

    PubMed 10607036

  • Duffy JF. Increased sleep disruption, reduced sleepiness in older subjects? Sleep. 2005 Nov;28(11):1358-9. No abstract available.

    PubMed 16335324

  • 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.

    PubMed 15283016

  • 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.

    PubMed 11803113

  • 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.

    PubMed 11480654

  • 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.

    PubMed 10841208

  • 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.

    PubMed 18274272

  • 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.

    PubMed 18729646

  • 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.

    PubMed 18419261

  • 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.

    PubMed 32364602

  • 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.

    PubMed 28973223

Questions about this trial

What is this clinical trial studying?

A study testing chronic sleep restriction in people with Aging and Sleep Deprivation, run by National Institute on Aging (NIA) 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 1 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: status not confirmed, as of the sponsor's last update on 29 Apr 2009. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in sleep and waking EEG measures (time frame: During 3-week chronic sleep restriction segment of inpatient study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00506428, which also lists 15 linked publications.

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 29 Apr 2009.

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