Magnetoencephalographic (MEG) Localization of Ramelteon's Effects on Brain Function and Cortical Arousal in Insomnia
The present protocol will utilize simultaneous recording of brain activity during attention and memory tasks in insomnia participants after ramelteon vs. zolpidem vs. placebo administration. The investigators hypothesize that amplitudes of associated with memory will be unchanged by ramelteon, whereas zolpidem will significantly reduce brain activity associated with stimulus processing as evidenced by abnormal reduction in the amplitude of specific brain regions relative to placebo.
|Study Design:||Time Perspective: Cross-Sectional|
|Official Title:||Magnetoencephalographic Localization of Ramelteon's Effects on Brain Function and Cortical Arousal in Insomnia|
|Study Start Date:||May 2008|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Insomniacs: Individuals reporting difficulty falling asleep or staying asleep within the past month for more than 3 days per week. Individuals much also meet screening criteria based on an overnight polysomnograph of latency to persistent sleep >20 minutes and/or >60 minutes of wake after sleep onset.
Controls: Individuals reporting no difficulty falling asleep or staying asleep and objective sleep measures based on an overnight polysomnograph of latency to persistent sleep <20 minutes and/or <60 minutes of wake after sleep onset.
The proposed research has two specific aims: 1) demonstrate that ramelteon has no effect on event related potential components that reflect basic sensory processes (P1 and N1), and will not impair attention and memory processes, whereas the benzodiazepine receptor agonist zolpidem will significantly reduce (relative to placebo) the amplitude of these event related potential components throughout the cerebral cortex and 2) show that ramelteon reduces the abnormal hyperarousal in insomnia as reflected through a reduction in the contingent negative variation component of the event related potential across frontal and parietal brain regions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688025
|United States, Michigan|
|Henry Ford Hospital Sleep Disorders & Research Center|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Christopher Drake, Ph.D.||Henry Ford Hospital Sleep Disorders & Research Center|