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Sleep Initiation and Maintenance DisordersNCT00427323

Light Exposure to Treat Sleep Disruption in Older People

A study testing light exposure in people with Sleep Initiation and Maintenance Disorders and Circadian Rhythm Sleep Disorders, run by National Institute on Aging (NIA) at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 55 to 80 yearsHealthy volunteers can take part
What is being tested?
light exposure
Type of treatment
Surgery or procedure
How many people
60 participants
Where
1 siteUnited States
Study dates
Jun 2006to Sep 2007
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 55 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Sleep complaint

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Disrupted Sleep in the Elderly: Light Exposure Studies

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.

Read the 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.

Being tested
light exposure
Keywords
sleep, aging, biological rhythm, melatonin, alertness, early morning awakening, daytime sleepiness, difficulty maintaining sleep, sleep maintenance insomnia
Medical subject headings
Sleep Initiation and Maintenance Disorders, Sleep Disorders, Circadian Rhythm, Disorders of Excessive Somnolence

What participants receive

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

  • light exposureProcedure or surgery

What is being measured

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

  1. change in sleep efficiency

  2. shift of circadian phase of melatonin secretion

Secondary outcomes (1)

  1. change in alertness and performance

Timeline

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

  1. First posted29 Jan 2007 (estimated)
  2. Study startJun 2006
  3. Primary completionSep 2007 (estimated)
  4. Study completionSep 2007 (estimated)

Why it stopped: recruitment has been put on hold until a future date

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00427323
Sponsor's protocol ID
AG0076
Other IDs
5R01AG006072-17
Status last verified
Sep 2007
First submitted
25 Jan 2007
Last updated
11 Dec 2009
Results posted
No

Publications

  • 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.

    PubMed 16621166

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

    PubMed 16077152

  • 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, 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.

    PubMed 11788360

  • 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

  • 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.

    PubMed 11217145

  • 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

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

    PubMed 10569297

  • Duffy JF, Dijk DJ, Klerman EB, Czeisler CA; New Collective Author. 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.

    PubMed 9791064

  • 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, Duffy JF; New Collective Author. 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.

    PubMed 10344586

Questions about this trial

What is this clinical trial studying?

A study testing light exposure in people with Sleep Initiation and Maintenance Disorders and Circadian Rhythm Sleep Disorders, 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 7 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: paused, as of the sponsor's last update on 11 Dec 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in sleep efficiency. The study lists 2 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 NCT00427323, which also lists 11 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 11 Dec 2009.

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