Light Exposure to Treat Sleep Disruption in Older People

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00427323
Recruitment Status : Suspended (recruitment has been put on hold until a future date)
First Posted : January 29, 2007
Last Update Posted : December 11, 2009
Information provided by:
National Institute on Aging (NIA)

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.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Circadian Rhythm Sleep Disorders Hypersomnia Procedure: light exposure Not Applicable

Detailed Description:

The endogenous circadian pacemaker (the natural biological rhythm of a 24-hour cycle) is a major determinant of the timing of sleep and sleep structure in humans. There are considerable data from animals and humans suggesting that the properties of the circadian pacemaker change with advancing age. It has been hypothesized that these changes may underlie the sleep disruption and reduction in daytime alertness observed in the elderly. Recent studies have confirmed the impact of endogenous circadian phase on REM sleep (Rapid Eye Movement--the period of sleep associated with dreaming) and have revealed that high sleep efficiency can only be maintained when there is a unique phase-relationship between the sleep episode and endogenous circadian phase. This phase-relationship is such that even a small change in the relative timing of the circadian pacemaker and the daily sleep episode can have a large impact on an individual's ability to consolidate sleep throughout the night, especially in older individuals.

In this field-laboratory study, participants will first be monitored for 3 weeks while living at home on a self-selected sleep-wake schedule. They will then enter the laboratory for a 13-day study. The laboratory study begins with 3 baseline days living on their habitual schedule, and participants will be allowed to leave the hospital each day, returning in the evening. After this 3-day baseline, the initial circadian phase will be estimated in a constant posture (CP protocol). This is followed by a 4-day light treatment, when the participant will be exposed to approximately a 2 hour light session each evening. As in the baseline, the participant will be allowed to leave the hospital during the daytime hours, returning in the early evening. Following the 4-day treatment, a second CP will be conducted. After the CP, a 3-day laboratory follow up will take place (similar to the baseline), and this will be followed by an ambulatory follow-up, where the participant will be monitored with an actigraphy monitor for 3 weeks while living at home (as in the ambulatory baseline). Sleep will be polysomnographically recorded (oxygen saturation, electrocardiography, air flow, respiratory effort, limb movement, eye and jaw muscle movement, and brain electrical activity) each night in the laboratory, blood samples will be collected during each CP so that the phase of the circadian rhythm of melatonin secretion can be assessed, and activity monitoring will continue from the ambulatory baseline through the ambulatory follow-up. Tests of performance and alertness will be conducted during the times the participant is awake in the laboratory.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Disrupted Sleep in the Elderly: Light Exposure Studies
Study Start Date : June 2006
Estimated Primary Completion Date : September 2007
Estimated Study Completion Date : September 2007

Primary Outcome Measures :
  1. change in sleep efficiency
  2. shift of circadian phase of melatonin secretion

Secondary Outcome Measures :
  1. change in alertness and performance

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Sleep complaint

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00427323

United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
National Institute on Aging (NIA)
Principal Investigator: Jeanne F Duffy, PhD Brigham and Women's Hospital

Publications: Identifier: NCT00427323     History of Changes
Other Study ID Numbers: AG0076
5R01AG006072-17 ( U.S. NIH Grant/Contract )
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: September 2007

Keywords provided by National Institute on Aging (NIA):
biological rhythm
early morning awakening
daytime sleepiness
difficulty maintaining sleep
sleep maintenance insomnia

Additional relevant MeSH terms:
Sleep Disorders, Circadian Rhythm
Sleep Wake Disorders
Sleep Initiation and Maintenance Disorders
Disorders of Excessive Somnolence
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Sleep Disorders, Intrinsic
Chronobiology Disorders
Occupational Diseases