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

Sponsor
Henry Ford Health System (Other)
Overall Status
Completed
CT.gov ID
NCT00688142
Collaborator
Cephalon (Industry)
24
Enrollment
1
Location
24.9
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    24 participants
    Time Perspective:
    Prospective
    Official Title:
    Magnetoencephalographic Imaging of Sleepiness: The Effect of Armodafinil in Shift Work Sleep Disorder
    Study Start Date :
    Feb 1, 2008
    Actual Primary Completion Date :
    Mar 1, 2010
    Actual Study Completion Date :
    Mar 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Individuals with shift work sleep disorder
    2

    Healthy night shift workers without shift work sleep disorder

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 55 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      • Night shift workers with and without shift work sleep disorder.
      Exclusion Criteria:
      • Secondary condition to shift work sleep disorder.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Henry Ford Hospital Sleep Disorders & Research Center Detroit Michigan United States 48202

      Sponsors and Collaborators

      • Henry Ford Health System
      • Cephalon

      Investigators

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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00688142
      Other Study ID Numbers:
      • C10953/6079/ES/US
      First Posted:
      Jun 2, 2008
      Last Update Posted:
      Mar 31, 2010
      Last Verified:
      Mar 1, 2010
      Additional relevant MeSH terms:
      Sleep Wake Disorders
      Parasomnias
      Sleep Disorders, Circadian Rhythm
      Sleepiness

      Study Results

      No Results Posted as of Mar 31, 2010