Sleep Initiation and Maintenance Disorders Clinical Trial
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.
Status | Suspended |
Enrollment | 60 |
Est. completion date | September 2007 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 55 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Brigham & Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
National Institute on Aging (NIA) |
United States,
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. — View Citation
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. Review. — View Citation
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):611-27. — View Citation
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. Review. — View Citation
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. — View Citation
Duffy JF, Wright KP Jr. Entrainment of the human circadian system by light. J Biol Rhythms. 2005 Aug;20(4):326-38. Review. — View Citation
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. Epub 2006 Apr 18. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in sleep efficiency | |||
Primary | shift of circadian phase of melatonin secretion | |||
Secondary | change in alertness and performance |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Recruiting |
NCT05000528 -
Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia
|
N/A | |
Completed |
NCT04661306 -
The Better Sleep for Supporters With Insomnia Study
|
N/A | |
Completed |
NCT03673397 -
The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression
|
N/A | |
Completed |
NCT01784614 -
A Study of LY2624803 in Japanese Participants With Transient Insomnia
|
Phase 1 | |
Completed |
NCT00365261 -
Effect of Eszopiclone on Sleep Disturbance and Pain in Cancer
|
Phase 4 | |
Completed |
NCT00380003 -
Efficacy Study of EVT 201 to Treat Insomnia
|
Phase 2 | |
Completed |
NCT00183378 -
Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease
|
N/A | |
Completed |
NCT00097604 -
Effects of Valerian on Sleep in Healthy Older Adults
|
Phase 2 | |
Completed |
NCT00946530 -
Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
|
N/A | |
Completed |
NCT00630175 -
Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia
|
Phase 3 | |
Completed |
NCT00079664 -
Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults
|
Phase 1 | |
Completed |
NCT00044629 -
Combined Behavioral/Pharmacological Therapy for Insomnia
|
Phase 2 | |
Completed |
NCT01154023 -
Behavioral Intervention for Insomnia in Older Adults
|
N/A | |
Recruiting |
NCT04417153 -
Who Benefits More? Optimising Mindfulness Based Interventions for Improved Psychological Outcomes
|
||
Completed |
NCT04560595 -
Remote Guided Caffeine Reduction
|
N/A | |
Recruiting |
NCT04986007 -
Addressing Nocturnal Sleep/Wake Effects on Risk of Suicide in Older Adults
|
N/A | |
Completed |
NCT03852966 -
Better Sleep in Psychiatric Care - ADHD Pilot Study
|
N/A | |
Terminated |
NCT00750919 -
Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)
|
Phase 3 | |
Recruiting |
NCT04550507 -
Mind-Body Interventions to Mitigate Effects of Media Use on Sleep in Early Adolescents
|
N/A |