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...
Date First Received: May 28, 2008
Last Updated: March 5, 2010
Verified by: Henry Ford Health System, March 2010
Clinical Trial Phase: N/A | Start Date: May 2008
Overall Status: Recruiting
Estimated Enrollment: 24
Brief Summary
Official Title: “Magnetoencephalographic Localization of Ramelteon's Effects on Brain Function and Cortical Arousal in Insomnia”
Condition Keyword(s):
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 Type: Observational
Study Design: Other, Cross-Sectional
Detailed Clinical Trial Description
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.
Arms, Groups and Cohorts in this Clinical Trial
- : 1
- Insomniacs
- : 2
- Controls
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Healthy individuals with no secondary condition to insomnia.
Exclusion Criteria:
- Healthy individuals with no insomnia.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 55 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Henry Ford Health System
Overall Clinical Trial Officials and Contacts
Christopher Drake, Ph.D. Principal Investigator Henry Ford Hospital Sleep Disorders & Research Center
Additional Information
Information obtained from ClinicalTrials.gov on March 10, 2010
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00688025
Study ID Number: 07-033R
ClinicalTrials.gov Identifier: NCT00688025
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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