Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome (NCT00593736) | Clinical Trial Compass
CompletedPhase 2
Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome
United States132 participantsStarted 2007-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Females of childbearing potential who is sexually active must agree to use adequate contraception from screening throughout the duration of the study.
* Must have a diagnosis of Delayed Sleep Phase Syndrome according to International Classification of Sleep Disorders criteria for at least 3 months.
* Based on sleep history, subject's habitual sleep time is more than 3 hours later than the desired sleep time.
* Must have had self reported insomnia which is defined per the sleep history as his or her sleep latency of at least 45 minutes when attempting to sleep at desired sleep time required by his or her work or school schedule.
* The subjective sleep latency via Post sleep questionnaire during outpatient screening period must be greater than or equal to 45 minutes during every working night or school night provided the subject went to bed at their desired sleep time.
* During single blind placebo run-in Polysomnography screening nights, subject is instructed to go to bed at their desired bed time and must demonstrate difficulty in falling asleep based on the following criteria:
* During Polysomnography screening nights when the subject goes to bed at their desired sleep time or
* The average of total wake time
* Is in good health as determined by a medical and psychiatric history, physical examination, Electrocardiogram, and serum chemistry and hematology.
* Is able to complete self-rating scales via interactive voice response system, and has a tou…
What they're measuring
1
Latency to Persistent Sleep Over a 2-night Average Measured by Polysomnography (Nights 6-7)