| Study Summary: |
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Circadian rhythm disorders are disruptions in an individual's circadian rhythm, or "internal
body clock." This internal clock regulates the 24-hour cycle of biological processes in the
body, including sleep and hormone production. Jet lag, delayed sleep phase syndrome, in
which individuals fall asleep and wake up later than desired, and advanced sleep phase
syndrome, in which individuals fall asleep and wake up earlier than desired, are all
examples of circadian rhythm disorders. Because of the disruptive nature of these
conditions, it is important to identify the quickest and most effective method for
regulating the body and reestablishing normal sleep patterns. Light therapy, in which
individuals are exposed to bright, artificial light, is currently used to treat these
disorders. Melatonin, a hormone that regulates circadian rhythms, and methylxanthines, a
class of stimulant medications, are other common non-light treatments. While each of these
individual treatments has been proven effective, little is known about the combined effect
of light and non-light treatments. The purpose of this study is to evaluate the safety and
effectiveness of light therapy, melatonin, and methylxanthine, alone and in combination, at
regulating circadian rhythms and improving sleep quality and cognitive function.
This study will enroll healthy individuals. Participants will first attend two screening
visits, which will include a review of medical, psychiatric, and sleep histories; vital sign
measurements; blood and urine collection; a physical examination; and an electrocardiogram.
For 1 week, participants will record sleep habits in a diary and by telephone. They will
also wear a device that monitors activity and light exposure levels. Eligible participants
will then attend four 5-day inpatient visits at the Sleep and Chronobiology Laboratory at
the University of Colorado at Boulder. During each of the four visits, participants will be
randomly assigned to one of the following four treatments:
- Dim light therapy and placebo
- Bright light therapy and placebo
- Dim light therapy, melatonin, and methylxanthines
- Bright light therapy, melatonin, and methylxanthines
At each visit, participants will receive a different treatment. During these visits,
participants will remain awake for up to 40 hours at a time, while their eye movements, and
brain, muscle, heart, and breathing activity are monitored. Urine and saliva will be
collected, and participants will undergo various cognitive performance testing measures. At
3-week intervals between each visit, participants will record sleep habits and will wear the
activity and light exposure monitoring device. A sleep diary will also be maintained by
participants for 3 weeks following the end of the last visit.
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| Criteria: |
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Inclusion Criteria:
- In good general health, as determined by blood chemistries, urine toxicology,
physical examination, and medical and psychiatric history
Exclusion Criteria:
- History of any current or chronic disease, including any of the following:
1. Chronobiologic disorders
2. Sleep disorders
3. Cardiovascular disorders
4. Respiratory disorders
5. Kidney and urinary tract disorders
6. Infectious diseases
7. Gastrointestinal disorders
8. Immune system disorders
9. Connective tissue and joint disorders
10. Hematopoietic disorders
11. Neoplastic diseases
12. Endocrine and metabolic diseases
13. Neurologic disorders
- Current or past history of drug abuse
- Pregnant or breastfeeding
- Current oral contraceptive use
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