Clinical Trials Directory

Trials / Completed

CompletedNCT00900159

Effects of Daytime Eszopiclone Administration in Shift Workers

Effects of Daytime Eszopiclone Administration in Shift Workers on Overnight Wakefulness During a Subsequent Simulated Nightshift

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Brigham and Women's Hospital · Academic / Other
Sex
All
Age
20 Years – 50 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to test the effects of eszopiclone on daytime sleep and overnight wakefulness in shift workers.

Detailed description

The current study seeks to extend the currently available treatments for SWSD by addressing the putative root cause of the problem-the inability of night-shift workers with or without SWSD- to obtain adequate daytime sleep in the face of the circadian drive for alertness that increases across the biological day. Even healthy, young subjects who are sleep-deprived overnight exhibit daytime sleep marked by frequent awakenings and low sleep efficiency, less slow-wave sleep, and altered sleep architecture, e.g. earlier predominance of REM sleep. Many night-workers routinely report 3-6 hours of habitual sleep duration for daytime sleep. Pharmacological interventions to decrease awakenings and improve total sleep time during daytime sleep could improve subsequent alertness during a night shift. Improving the wakefulness of night-shift workers over the nighttime could result in substantial benefits for the individual workers, improve workplace productivity and safety, and improve public health.

Conditions

Interventions

TypeNameDescription
DRUGeszopiclone3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)
DRUGmatching placebomatching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)

Timeline

Start date
2009-05-01
Primary completion
2010-01-01
Completion
2010-02-01
First posted
2009-05-12
Last updated
2017-08-30
Results posted
2017-08-30

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00900159. Inclusion in this directory is not an endorsement.