Clinical Trial: Effectiveness of Combining Light and Non-Light Treatments for Jet Lag and Sleep Disorders
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Circadian Integration of Photic and Non-photic Stimuli
Brief Summary: Jet lag and some sleep disorders are caused by a disruption in an individual's "internal clock." Understanding the most effective way to quickly re-adjust the body's internal clock will be beneficial for treating individuals with these conditions. This study will evaluate the combined effectiveness of light and non-light therapies at regulating sleep cycles and improving sleep quality.
Detailed Summary:
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 Bou
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Current Primary Outcome: Circadian phase, as measured by the shift of the endogenous melatonin rhythm (measured during each inpatient visit) [ Time Frame: 24 hour ]
Original Primary Outcome: Circadian phase, as measured by the shift of the endogenous melatonin rhythm (measured during each inpatient visit)
Current Secondary Outcome:
- Circadian phase, as measured by the shift of the endogenous temperature rhythm [ Time Frame: 24 hour ]
- Sleep quality, as measured by wakefulness after sleep onset (electroencephalogram [EEG] defined wakefulness after 10 minutes of consecutive sleep) and number of awakenings [ Time Frame: overnight ]
- Cognitive function, as measured by daytime sleepiness, reaction time, and mood and well being (all measured during each inpatient visit) [ Time Frame: 24 h and daytime ]
Original Secondary Outcome:
- Circadian phase, as measured by the shift of the endogenous temperature rhythm
- Sleep quality, as measured by wakefulness after sleep onset (electroencephalogram [EEG] defined wakefulness after 10 minutes of consecutive sleep) and number of awakenings
- Cognitive function, as measured by daytime sleepiness, reaction time, and mood and well being (all measured during each inpatient visit)
Information By: National Heart, Lung, and Blood Institute (NHLBI)
Dates:
Date Received: October 11, 2006
Date Started: October 2006
Date Completion: March 2010
Last Updated: August 24, 2009
Last Verified: August 2009
