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

Shift Work Sleep Disorder Clinical Trial

Official title:

Magnetoencephalographic Imaging of Sleepiness: The Effect of Armodafinil in Shift Work Sleep Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688142
• Other study ID #: C10953/6079/ES/US
• 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

• Parasomnias
• Shift Work Sleep Disorder
• Sleep Disorders
• Sleep Disorders, Circadian Rhythm

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,