Effects of Daytime Eszopiclone Administration in Shift Workers

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-02-28

Brief Summary

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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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Detailed Description

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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

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Shift-Work Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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eszopiclone

Treatment with eszopiclone

Group Type EXPERIMENTAL

eszopiclone

Intervention Type DRUG

3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)

matching placebo

Treatment with matching placebo

Group Type PLACEBO_COMPARATOR

eszopiclone

Intervention Type DRUG

3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)

matching placebo

Intervention Type DRUG

matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)

Interventions

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eszopiclone

3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)

Intervention Type DRUG

matching placebo

matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)

Intervention Type DRUG

Other Intervention Names

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Lunesta placebo

Eligibility Criteria

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Inclusion Criteria

* Age 20-50 (men or women)
* Current shift worker (for at least 3 months, at least 5 overnights/month and 3 consecutive)
* A willingness and ability to comply with study procedures
* If of child-bearing potential, using a medically-accepted method of birth control, including abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method, or intrauterine device \[IUD\]).

Exclusion Criteria

* Current diagnosis of DSM-IV Axis I disorder (other than insomnia)
* Regular treatment (\>1time/wk) with CNS-active medication within 1 month of first inpatient visit
* Uncontrolled medical illness that would interfere with participation in the study
* BMI\>32 or \< 19.8 kg/m2
* Current symptoms or diagnosis of any moderate to severe sleep disorder other than SWSD
* Periodic Leg Movement of Sleep Index (PLMSi)\>20/hr of sleep or Respiratory Desaturation Index (RDI)\>15 on polysomnography (PSG)
* Current alcohol or drug dependence/abuse
* Menopausal or peri-menopausal symptoms that disrupt sleep
* Pregnant, lactating, or planning to become pregnant
* Current smoking of more than 10 cigarettes per day
* Current use of over the counter sleep aids such as Benadryl or melatonin

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes