Circadian Dysregulation Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Ability of Ramelteon 1 mg, 4 mg, and 8 mg to Alleviate the Insomnia Symptoms Associated With Eastward Bound Jet Lag Across 5 Time Zones in Healthy Adult Volunteers
The purpose of this study to determine the degree to which ramelteon, once daily (QD), can reduce the insomnia symptoms associated with rapid, eastward travel across 5 time zones.
Circadian dysrhythmia, or jet lag, is defined as multiple biologic and psychologic stresses
created by rapid travel across multiple time zones. As more people are transported by jet
aircraft, the issue of jet lag becomes more important. What was an inconvenience during
travel for leisure is now a physiologic consequence for the travelers and crew.
Jet lag is composed of a variety of unpleasant symptoms that vary with the number of time
zones crossed, the individual, and even the direction flown (east versus west). The most
typical symptoms include daytime sleepiness, fatigue, impaired alertness, and trouble
initiating and maintaining sleep. Other symptoms of circadian dysrhythmia are insomnia,
gastrointestinal complaints, apathy, weakness, irritability, malaise, and loss of appetite.
Travel across time zones also has been associated with diabetic ketoacidosis, depression,
and impaired cognitive performance in individuals at risk. Decreased sport performance has
been noted in several studies.
In addition to environmental and social cues, physical factors, such as age, hydration
status, and illness, could adversely affect the ability to entrain (adjust) quickly. The
stressors of flight, noise, vibration, decreased humidity, barometric pressure changes, and
decreased partial pressure of oxygen all contribute to crew and travelers health at the
destination.
Being out of synchronicity with the environment causes jet lag symptoms. Travel through time
zones places the body in a situation when it must sleep when not tired and awaken when the
internal cues are initiating sleep. The brain's internal clock is the suprachiasmatic
nucleus within the hypothalamus the body is in a constant state of circadian adjustment to
remain entrained to a given time zone. In addition to the subjective feeling of well being
are measurable changes associated with daily patterns. For example, core body temperature
changes throughout the day and decreases before falling asleep. Melatonin levels increase in
the evening and night and recede during the day.
Ramelteon is a melatonin receptor 1 and melatonin receptor 2 agonist currently marketed in
the US for the treatment of insomnia characterized by difficulty with sleep onset. Study
participation is anticipated to be about 2 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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