NCT00427323

Brief Summary

The purpose of this study is to test whether shifts in the timing of the biological clock to a later hour (phase delay shifts of the human circadian system) can be produced in response to four successive evenings of light exposure, and whether that phase shift will result in greater evening alertness and greater nighttime sleep efficiency. Three different light sources will be compared: 1) standard fluorescent light; 2) blue-enriched light; 3) incandescent fluorescent light.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
suspended

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

June 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

December 11, 2009

Status Verified

September 1, 2007

Enrollment Period

1.3 years

First QC Date

January 25, 2007

Last Update Submit

December 10, 2009

Conditions

Keywords

sleepagingbiological rhythmmelatoninalertnessearly morning awakeningdaytime sleepinessdifficulty maintaining sleepsleep maintenance insomnia

Outcome Measures

Primary Outcomes (2)

  • change in sleep efficiency

  • shift of circadian phase of melatonin secretion

Secondary Outcomes (1)

  • change in alertness and performance

Interventions

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sleep complaint

You may not qualify if:

  • Sleep apnea
  • Depression
  • Periodic limb movements of sleep
  • Restless Legs Syndrome
  • History of stroke
  • History of heart attack
  • Uncontrolled medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (11)

  • Duffy JF, Zeitzer JM, Czeisler CA. Decreased sensitivity to phase-delaying effects of moderate intensity light in older subjects. Neurobiol Aging. 2007 May;28(5):799-807. doi: 10.1016/j.neurobiolaging.2006.03.005. Epub 2006 Apr 18.

    PMID: 16621166BACKGROUND
  • Duffy JF, Wright KP Jr. Entrainment of the human circadian system by light. J Biol Rhythms. 2005 Aug;20(4):326-38. doi: 10.1177/0748730405277983.

    PMID: 16077152BACKGROUND
  • 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, Zeitzer JM, Rimmer DW, Klerman EB, Dijk DJ, Czeisler CA. Peak of circadian melatonin rhythm occurs later within the sleep of older subjects. Am J Physiol Endocrinol Metab. 2002 Feb;282(2):E297-303. doi: 10.1152/ajpendo.00268.2001.

    PMID: 11788360BACKGROUND
  • 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
  • Klerman EB, Duffy JF, Dijk DJ, Czeisler CA. Circadian phase resetting in older people by ocular bright light exposure. J Investig Med. 2001 Jan;49(1):30-40. doi: 10.2310/6650.2001.34088.

    PMID: 11217145BACKGROUND
  • 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
  • Zeitzer JM, Daniels JE, Duffy JF, Klerman EB, Shanahan TL, Dijk DJ, Czeisler CA. Do plasma melatonin concentrations decline with age? Am J Med. 1999 Nov;107(5):432-6. doi: 10.1016/s0002-9343(99)00266-1.

    PMID: 10569297BACKGROUND
  • Duffy JF, Dijk DJ, Klerman EB, Czeisler CA. Later endogenous circadian temperature nadir relative to an earlier wake time in older people. Am J Physiol. 1998 Nov;275(5 Pt 2):R1478-87. doi: 10.1152/ajpregu.1998.275.5.r1478.

    PMID: 9791064BACKGROUND
  • 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, Duffy JF. Circadian regulation of human sleep and age-related changes in its timing, consolidation and EEG characteristics. Ann Med. 1999 Apr;31(2):130-40. doi: 10.3109/07853899908998789.

    PMID: 10344586BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Disorders, Circadian RhythmDisorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersChronobiology DisordersOccupational Diseases

Study Officials

  • Jeanne F Duffy, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

June 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

December 11, 2009

Record last verified: 2007-09

Locations