Light Exposure to Treat Sleep Disruption in Older People

This study has suspended participant recruitment.
(recruitment has been put on hold until a future date)
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00427323
First received: January 25, 2007
Last updated: December 10, 2009
Last verified: September 2007
  Purpose

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 Intervention
Sleep Initiation and Maintenance Disorders
Circadian Rhythm Sleep Disorders
Hypersomnia
Procedure: light exposure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Disrupted Sleep in the Elderly: Light Exposure Studies

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • change in sleep efficiency
  • shift of circadian phase of melatonin secretion

Secondary Outcome Measures:
  • change in alertness and performance

Estimated Enrollment: 60
Study Start Date: June 2006
Estimated Study Completion Date: September 2007
Estimated Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427323

Locations
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Investigators
Principal Investigator: Jeanne F Duffy, PhD Brigham and Women's Hospital
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00427323     History of Changes
Other Study ID Numbers: AG0076, 5R01AG006072-17
Study First Received: January 25, 2007
Last Updated: December 10, 2009
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Sleep Disorders, Circadian Rhythm
Disease
Sleep Disorders
Parasomnias
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases

ClinicalTrials.gov processed this record on September 29, 2014