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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00688142
Other study ID # C10953/6079/ES/US
Secondary ID
Status Completed
Phase N/A
First received May 28, 2008
Last updated March 30, 2010
Start date February 2008
Est. completion date March 2010

Study information

Verified date March 2010
Source Henry Ford Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Secondary condition to shift work sleep disorder.

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Henry Ford Hospital Sleep Disorders & Research Center Detroit Michigan

Sponsors (2)

Lead Sponsor Collaborator
Henry Ford Health System Cephalon

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT00080288 - Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD Phase 3
Terminated NCT01792583 - The Nuvigil and Provigil Pregnancy Registry