Magnetoencephalographic (MEG) Localization of Ramelteons Effects on Brain Function and Cortical Arousal in Insomnia

This study is currently recruiting participants.

Verified by Henry Ford Health System, January 2009

First Received: May 28, 2008 Last Updated: January 29, 2009 History of Changes

Sponsor:	Henry Ford Health System
Collaborator:	Takeda Pharmaceuticals North America, Inc.
Information provided by:	Henry Ford Health System
ClinicalTrials.gov Identifier:	NCT00688025

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 barin 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:	Cross-Sectional
Official Title:	Magnetoencephalographic Localization of Ramelteon's Effects on Brain Function and Cortical Arousal in Insomnia

Resource links provided by NLM:

Drug Information available for: Ramelteon

U.S. FDA Resources

Further study details as provided by Henry Ford Health System:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	24
Study Start Date:	May 2008
Estimated Study Completion Date:	September 2009

Groups/Cohorts
1 Insomniacs
2 Controls

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688025

Locations

United States, Michigan
Henry Ford Hospital Sleep Disorders & Research Center	Recruiting
Detroit, Michigan, United States, 48202
Contact: Christopher Drake, Ph.D. 313-916-4455
Principal Investigator: Christopher Drake, Ph.D.

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:	Henry Ford Health System ( Christopher Drake, Ph.D. )
Study ID Numbers:	07-033R
Study First Received:	May 28, 2008
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00688025 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Nervous System Diseases

Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on February 08, 2010