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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00688025
First Posted: June 2, 2008
Last Update Posted: March 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by:
Henry Ford Health System
  Purpose
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
Insomnia

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Magnetoencephalographic Localization of Ramelteon's Effects on Brain Function and Cortical Arousal in Insomnia

Further study details as provided by Henry Ford Health System:

Enrollment: 24
Study Start Date: May 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Insomniacs, individuals with difficulty falling asleep or staying asleep.
Criteria

Inclusion Criteria:

  • Healthy individuals with no secondary condition to insomnia.

Exclusion Criteria:

  • Healthy individuals with no insomnia.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688025


Locations
United States, Michigan
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
  More Information

Responsible Party: Christopher Drake, Ph.D., Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00688025     History of Changes
Other Study ID Numbers: 07-033R
First Submitted: May 28, 2008
First Posted: June 2, 2008
Last Update Posted: March 31, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders