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

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00688142
First received: May 28, 2008
Last updated: March 30, 2010
Last verified: March 2010

May 28, 2008
March 30, 2010
February 2008
March 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00688142 on ClinicalTrials.gov Archive Site
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Sleepiness and Brain Function: The Effect of Armodafinil in Shift Work Sleep Disorder
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.

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.

Observational
Time Perspective: Prospective
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Probability Sample

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

Shift Work Sleep Disorder
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  • 1
    Individuals with shift work sleep disorder
  • 2
    Healthy night shift workers without shift work sleep disorder
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Secondary condition to shift work sleep disorder.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00688142
C10953/6079/ES/US
No
Christopher Drake, Ph.D., Henry Ford Health System
Henry Ford Health System
Cephalon
Principal Investigator: Christopher Drake, Ph.D. Henry Ford Hospital Sleep Disorders & Research Center
Henry Ford Health System
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP