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

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00688025
First received: May 28, 2008
Last updated: March 30, 2010
Last verified: March 2010
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Christopher Drake, Ph.D., Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00688025     History of Changes
Other Study ID Numbers: 07-033R
Study First Received: May 28, 2008
Last Updated: March 30, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 01, 2014