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

NCT ID: NCT00688025

Last Updated: 2010-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Insomnia

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Healthy individuals with no secondary condition to insomnia.

Exclusion Criteria

* Healthy individuals with no insomnia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Takeda Pharmaceuticals North America, Inc.

INDUSTRY

Sponsor Role collaborator

Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Henry Ford Health System

Principal Investigators

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Christopher Drake, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Hospital Sleep Disorders & Research Center

Locations

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Henry Ford Hospital Sleep Disorders & Research Center

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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07-033R

Identifier Type: -

Identifier Source: org_study_id