Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT00900159
The purpose of this study is to test the effects of eszopiclone on daytime sleep and overnight wakefulness in shift workers.
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Notify Me20 year–50 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)
Other names: Lunesta
matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)
Other names: placebo
Time frame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
Participants underwent four Maintenance of Wakefulness Tests (MWT) at 2-hour intervals during the simulated night shift starting 5 hours after wake time. MWT range from 0 to 40 minutes, where shorter times to fall asleep represent greater sleepiness (worse). MWT tests are averaged, for a mean in minutes.
Time frame: On each treatment, during an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts
Polysomnographic recordings of daytime sleep were made at sleep screen (8.5hr) and during daytime sleep episodes of 8.5 hours of duration during treatment visits. Sleep efficiency is calculated based on the time the participant spent in bed and the actual time the participant slept.
Time frame: On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts
The Karolinska Sleepiness Scale (KSS), a nine point Visual Analog Scale of alertness/sleepiness, was used to assess subjective sleepiness. The KSS is a scale from 1 to 9, from minimum to maximum sleepiness.
Time frame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
A computer-based Flanker Task elicits responses to an incongruent pairing of stimuli measured as reaction time, in milliseconds. The Flanker task tests response inhibition, or the participants suppression of an unwanted response. A target stimulus (symbol) is "flanked" by non-target stimuli (symbols) that are the same as the target stimulus, opposite of the target stimulus, or neutral with respect to the target stimulus. The task is intended to assess the ability to maintain "selective attention" in the presence of distractors.
Time frame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
A computer-based Word-pair tasks is the number of words recalled after sleep from a list of words shown prior to going to sleep.
Brigham and Women's Hospital
Other
Effects of Daytime Eszopiclone Administration in Shift Workers on Overnight Wakefulness During a Subsequent Simulated Nightshift
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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