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

March 30, 2010 updated by: Henry Ford Health System

Magnetoencephalographic Imaging of Sleepiness: The Effect of Armodafinil in Shift Work Sleep Disorder

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital Sleep Disorders & Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study population must be healthy night shift workers with a diagnosis of shift work sleep disorder.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Secondary condition to shift work sleep disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Individuals with shift work sleep disorder
2
Healthy night shift workers without shift work sleep disorder

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Collaborators

Cephalon

Investigators

  • Principal Investigator: Christopher Drake, Ph.D., Henry Ford Hospital Sleep Disorders & Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

May 28, 2008

First Submitted That Met QC Criteria

May 28, 2008

First Posted (Estimate)

June 2, 2008

Study Record Updates

Last Update Posted (Estimate)

March 31, 2010

Last Update Submitted That Met QC Criteria

March 30, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C10953/6079/ES/US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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