NCT00506428

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2007

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 29, 2009

Status Verified

April 1, 2009

Enrollment Period

4.5 years

First QC Date

April 27, 2007

Last Update Submit

April 28, 2009

Conditions

AgingSleep DeprivationMetabolic Syndrome

Keywords

agingsleepsleep deprivationperformancememorymetabolism

Outcome Measures

Primary Outcomes (3)

  • Changes in sleep and waking EEG measures

    During 3-week chronic sleep restriction segment of inpatient study

  • frequent measures of performance, attention, alertness, and memory

    During 3-week chronic sleep restriction segment of inpatient study

  • measures of cardiovascular and metabolic function

    During 3-week chronic sleep restriction segment of inpatient study

Interventions

chronic sleep restrictionBEHAVIORAL

5.6 hours of sleep per 24 hours for 3 weeks

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (15)

  • 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.

    PMID: 10381883BACKGROUND

  • 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.

    PMID: 10087357BACKGROUND

  • 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.

    PMID: 9457658BACKGROUND

  • 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.

    PMID: 9040282BACKGROUND

  • 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.

    PMID: 10607036BACKGROUND

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

    PMID: 16335324BACKGROUND

  • 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.

    PMID: 15283016BACKGROUND

  • 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.

    PMID: 11803113BACKGROUND

  • 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.

    PMID: 11480654BACKGROUND

  • 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.

    PMID: 10841208BACKGROUND

  • 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.

    PMID: 18274272BACKGROUND

  • 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.

    PMID: 18729646BACKGROUND

  • 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.

    PMID: 18419261BACKGROUND

  • 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.

    PMID: 32364602DERIVED

  • 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.

    PMID: 28973223DERIVED

MeSH Terms

Conditions

Sleep DeprivationMetabolic Syndrome

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Charles A Czeisler, PhD, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

April 27, 2007

First Posted

July 25, 2007

Study Start

December 1, 2006

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 29, 2009

Record last verified: 2009-04

Locations

US(1)