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
  Purpose

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
Shift Work Sleep Disorder

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Magnetoencephalographic Imaging of Sleepiness: The Effect of Armodafinil in Shift Work Sleep Disorder

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Enrollment: 24
Study Start Date: February 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Individuals with shift work sleep disorder
2
Healthy night shift workers without shift work sleep disorder

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Secondary condition to shift work sleep disorder.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00688142

Locations
United States, Michigan
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
  More Information

No publications provided

Responsible Party: Christopher Drake, Ph.D., Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00688142     History of Changes
Other Study ID Numbers: C10953/6079/ES/US
Study First Received: May 28, 2008
Last Updated: March 30, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sleep Disorders
Parasomnias
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 22, 2014