An interventional study of Bright light box in Sleep Disorders, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-08.
Sponsored by Rush University Medical Center · Not applicable, Interventional, and Basic science
This research will examine why sleep restriction reduces the body clock's response to bright light. The results will enable the optimization of the bright light treatment of people who suffer from circadian rhythm sleep disorders, which include shift work sleep disorder, jet lag, delayed sleep phase syndrome and winter depression, thereby improving public health and safety, well-being, mood, mental function, and quality of life.
Millions of Americans suffer from circadian rhythm sleep disorders, which include shift work sleep disorder, jet lag, delayed sleep phase syndrome and possibly winter depression. These conditions are typically characterized by persistent insomnia and/or excessive daytime sleepiness, impaired performance, and gastrointestinal distress. These negative symptoms result from a misalignment between the timing of the external social world and the timing of the internal circadian (body) clock. Circadian rhythm sleep disorders are effectively treated with bright light, which phase shifts the circadian clock, thereby realigning it with the timing of the external social world.
It is widely recognized that social influences have led to an increasing prevalence of sleep restriction in modern society. We recently demonstrated for the first time that short sleep episodes, when compared to long sleep episodes, markedly reduce phase advances to bright light. Thus when people cut their sleep short, they inadvertently reduce their circadian responsiveness to bright light. The mechanism(s) behind these reduced phase shifts to light are unknown. However, there are at least two aspects of short sleep episodes that could be responsible for this effect. First, short sleep episodes are associated with partial sleep deprivation. Second, as humans sleep with their eyes closed and are usually exposed to light when awake, short sleep episodes are also associated with short dark lengths. Our overall goal is to determine the biobehavioral mechanisms by which short sleep episodes impair phase shifts to bright light. Specific Aim 1 is to determine the effect of partial sleep deprivation on phase advances to light, while controlling for dark length. Specific Aim 2 is to determine the effect of short dark lengths on phase advances to light while minimizing sleep deprivation. We will estimate the timing of the human circadian clock by measuring salivary melatonin, a neuroendocrine hormone released from the pineal gland, and collecting measures of sleep via actigraphy, and sleepiness, mood, gastrointestinal distress and cognitive performance via computerized assessment.
Characterization of the separate effects of sleep deprivation and dark length on circadian phase shifts to light in humans is critical to understanding how humans respond to light during their daily life activities. Furthermore, the findings of this research will produce important and practical recommendations for avoiding decrements to phase shifts to light, thereby optimizing the bright light treatment of circadian rhythm sleep disorders, and thus improving public health and safety, well-being, mood, cognitive function, and quality of life.
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's enrollment of 16 is below the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Bright light box
Device: Bright light box
Bright light of about 5000 lux, administered while sitting at a desk.
Dim Light Melatonin Onset (Hours)
Gold standard marker of circadian timing
Time frame: 12 days from baseline to final dim light melatonin onset
Psychomotor Vigilance
Fastest 10% reaction time (msec)
Time frame: after short or long nights
| Milestone | 9 Hour Sleep (3days), Then 3 Hour Nap and 6 Hour Sleep (3days) | 3 Hour Nap and 6 Hour Sleep (3days), Then 9 Hour Sleep (3days) |
|---|---|---|
| Started | 8 | 8 |
| Completed | 6 | 6 |
| Not completed | 2 | 2 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Protocol violation | 1 | 1 |
Gold standard marker of circadian timing
| hours | 9 Hour Sleep | 3 Hour Nap and 6 Hour Sleep |
|---|---|---|
| Dim Light Melatonin Onset (Hours) | 1.93 ± 0.98 | 0.80 ± 0.92 |
Fastest 10% reaction time (msec)
| msec | 9 Hour Sleep | 3 Hour Nap and 6 Hour Sleep |
|---|---|---|
| Psychomotor Vigilance | 215.15 ± 32.57 | 221.16 ± 33.56 |
Collected over Duration of study = 48 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 9 Hour Sleep | — | 0/8 (0%) | 0/8 (0%) |
| 3 Hour Nap and 6 Hour Sleep | — | 0/8 (0%) | 0/8 (0%) |
| Age, Continuous(years) | 9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep | 3 Hour Nap and 6 Hour Sleep, Then 9 Hour Nap | Total |
|---|---|---|---|
| Mean | 30.5 ± 9.0 | 26.5 ± 5.8 | 28.5 ± 7.5 |
| Sex: Female, Male(Participants) | 9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep | 3 Hour Nap and 6 Hour Sleep, Then 9 Hour Nap | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 4 | 4 | 8 |
| Ethnicity (NIH/OMB)(Participants) | 9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep | 3 Hour Nap and 6 Hour Sleep, Then 9 Hour Nap | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 8 | 6 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep | 3 Hour Nap and 6 Hour Sleep, Then 9 Hour Nap | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 2 | 8 |
| White | 2 | 4 | 6 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | 9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep | 3 Hour Nap and 6 Hour Sleep, Then 9 Hour Nap | Total |
|---|---|---|---|
| United States | 8 | 8 | 16 |
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Rush University Medical Center