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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
NCT00946530 -
Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
|
N/A | |
Completed |
NCT00097604 -
Effects of Valerian on Sleep in Healthy Older Adults
|
Phase 2 | |
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 |
NCT00044629 -
Combined Behavioral/Pharmacological Therapy for Insomnia
|
Phase 2 | |
Completed |
NCT00079664 -
Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults
|
Phase 1 | |
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 |