NCT00688142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 31, 2010

Status Verified

March 1, 2010

Enrollment Period

2.1 years

First QC Date

May 28, 2008

Last Update Submit

March 30, 2010

Conditions

Shift Work Sleep Disorder

Study Arms (2)

1

Individuals with shift work sleep disorder

2

Healthy night shift workers without shift work sleep disorder

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Secondary condition to shift work sleep disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital Sleep Disorders & Research Center

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Chronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental Disorders

Study Officials

  • Christopher Drake, Ph.D.

    Henry Ford Hospital Sleep Disorders & Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2008

First Posted

June 2, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 31, 2010

Record last verified: 2010-03

Locations

US(1)