Sleep Disorders, Circadian Rhythm Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel, Proof of Concept Study to Evaluate the Effectiveness of Ramelteon to Advance the Timing of Sleep in Individuals With Delayed Sleep Phase Syndrome (DSPS)
The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.
Delayed sleep phase syndrome is the most common circadian disorder in adolescents and most
adults with the condition report onset of symptoms during childhood or adolescence. Delayed
Sleep Phase Syndrome involves a chronic mismatch between the usual daily schedule required
by the individual's environment and his or her circadian sleep wake pattern. Individuals
suffering from delayed Sleep Phase Syndrome experience great difficulty when attempting to
fall asleep before 1-2 am, if not later, as well as rising at acceptable hours of the
morning despite having completely normal sleep architecture and sleep duration. Delayed
Sleep Phase Syndrome is a sleep disorder that results from a dysregulation of the circadian
sleep-wake rhythm. Delayed Sleep Phase Syndrome is often the cause of severe insomnia and is
associated with excessive daytime sleepiness, major depressive disorder and severe
disruption of education, work and social functioning. Its major symptom is extreme
difficulty initiating sleep at a conventional hour and waking on time in the morning for
school or work.
Ramelteon is a selective melatonin type 1 (MT1) and type 2 (MT2) receptor agonist. The
purpose of this study is to evaluate the ability of ramelteon to advance the timing of sleep
in individuals with delayed sleep phase syndrome. The effect of ramelteon will be analyzed
based on collection of information from a post-sleep questionnaire completed by
participants, and data collected by polysomnography in a sleep clinic setting. Total
participation time involved in this study will be approximately 7 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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