Effects of Daytime Eszopiclone Administration in Shift Workers

Overview

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

Full Title of Study: “Effects of Daytime Eszopiclone Administration in Shift Workers on Overnight Wakefulness During a Subsequent Simulated Nightshift”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2010

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.

Interventions

  • Drug: eszopiclone
    • 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)
  • Drug: matching placebo
    • matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)

Arms, Groups and Cohorts

  • Experimental: eszopiclone
    • Treatment with eszopiclone
  • Placebo Comparator: matching placebo
    • Treatment with matching placebo

Clinical Trial Outcome Measures

Primary Measures

  • Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests
    • 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.

Secondary Measures

  • EEG-recorded Sleep Efficiency
    • 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.
  • Subjective Sleepiness and Performance
    • 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.
  • Objective Vigilance Task Performance
    • 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.
  • Sleep-dependent Memory Consolidation
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Brigham and Women’s Hospital
  • Collaborator
    • Sunovion
  • Provider of Information About this Clinical Study
    • Principal Investigator: Orfeu M. Buxton, Dr. Orfeu Buxton, Ph.D. – Brigham and Women’s Hospital
  • Overall Official(s)
    • Orfeu M Buxton, Ph.D., Principal Investigator, Brigham and Women’s Hospital

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