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Sleepiness and Brain Function: The Effect of Armodafinil in Shift Work Sleep Disorder

NCT ID: NCT00688142

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

2008-02-29

Study Completion Date

2010-03-31

Brief Summary

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The investigators hypothesize that in patients with shift work sleep disorder, armodafinil will specifically increase brain activity in the frontal cortex parallel with improvements in deficits of fundamental mechanisms of attention.

Detailed Description

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The current protocol will utilize a paradigm which is well suited to examine frontal attentional neuronal mechanisms by eliciting event related potential components known to reflect automatic stimulus detection as well as involuntary and voluntary attentional processes. The that end the proposed research has two specific aims. 1) Identify what areas of the frontal lobe and corresponding cognitive functions are impacted by excessive sleepiness in shift work sleep disorder and 2) identify specific brain areas affected by armodafinil and their role in improvement of fundamental attentional processes using a complex cognitive task targeting attentional control.

Conditions

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Shift Work Sleep Disorder

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

Individuals with shift work sleep disorder

No interventions assigned to this group

2

Healthy night shift workers without shift work sleep disorder

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Night shift workers with and without shift work sleep disorder.

Exclusion Criteria

* Secondary condition to shift work sleep disorder.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cephalon

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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C10953/6079/ES/US

Identifier Type: -

Identifier Source: org_study_id