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

Sponsor
Henry Ford Health System (Other)
Overall Status
Completed
CT.gov ID
NCT00688025
Collaborator
Takeda Pharmaceuticals North America, Inc. (Industry)
24
Enrollment
1
Location
22
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    24 participants
    Time Perspective:
    Cross-Sectional
    Official Title:
    Magnetoencephalographic Localization of Ramelteon's Effects on Brain Function and Cortical Arousal in Insomnia
    Study Start Date :
    May 1, 2008
    Actual Primary Completion Date :
    Mar 1, 2010
    Actual Study Completion Date :
    Mar 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 55 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      • Healthy individuals with no secondary condition to insomnia.
      Exclusion Criteria:
      • Healthy individuals with no insomnia.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Henry Ford Hospital Sleep Disorders & Research Center Detroit Michigan United States 48202

      Sponsors and Collaborators

      • Henry Ford Health System
      • Takeda Pharmaceuticals North America, Inc.

      Investigators

      • Principal Investigator: Christopher Drake, Ph.D., Henry Ford Hospital Sleep Disorders & Research Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00688025
      Other Study ID Numbers:
      • 07-033R
      First Posted:
      Jun 2, 2008
      Last Update Posted:
      Mar 31, 2010
      Last Verified:
      Mar 1, 2010
      Additional relevant MeSH terms:
      Sleep Initiation and Maintenance Disorders

      Study Results

      No Results Posted as of Mar 31, 2010