We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00688142
First Posted: June 2, 2008
Last Update Posted: March 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cephalon
Information provided by:
Henry Ford Health System
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 28, 2008
First Posted: June 2, 2008
Last Update Posted: March 31, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Disease
Sleep Wake Disorders
Parasomnias
Sleep Disorders, Circadian Rhythm
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases
Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action


To Top