Magnetoencephalographic (MEG) Localization of Ramelteon's Effects on Brain Function and Cortical Arousal in Insomnia

Magnetoencephalographic 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 Overview

• Status: Completed
• Conditions: Insomnia

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital Sleep Disorders & Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Insomniacs, individuals with difficulty falling asleep or staying asleep.

Description

Inclusion Criteria:

• Healthy individuals with no secondary condition to insomnia.

Exclusion Criteria:

• Healthy individuals with no insomnia.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; 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.
2; 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.

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: Takeda Pharmaceuticals North America, Inc.
• Investigators: Principal Investigator: Christopher Drake, Ph.D., Henry Ford Hospital Sleep Disorders & Research Center

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: May 28, 2008
• First Submitted That Met QC Criteria: May 30, 2008
• First Posted (Estimate): June 2, 2008

Study Record Updates

• Last Update Posted (Estimate): March 31, 2010
• Last Update Submitted That Met QC Criteria: March 30, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 07-033R