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Effects of Daytime Eszopiclone Administration in Shift Workers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00900159
First Posted: May 12, 2009
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Sunovion
Massachusetts General Hospital
Information provided by (Responsible Party):
Orfeu M. Buxton, Brigham and Women's Hospital
April 13, 2009
May 12, 2009
March 30, 2017
August 30, 2017
August 30, 2017
May 2009
January 2010   (Final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT00900159 on ClinicalTrials.gov Archive Site
  • 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.
  • EEG-recorded Sleep Efficiency [ Time Frame: On each treatment, during an 8.5-hr daytime sleep episode follwing at least 3 consecutive night shifts ]
  • Subjective Sleepiness and Performance [ Time Frame: On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts ]
  • Objective Vigilance Task Performance [ Time Frame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts ]
  • Sleep-dependent Memory Consolidation [ Time Frame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts ]
Not Provided
Not Provided
 
Effects of Daytime Eszopiclone Administration in Shift Workers
Effects of Daytime Eszopiclone Administration in Shift Workers on Overnight Wakefulness During a Subsequent Simulated Nightshift
The purpose of this study is to test the effects of eszopiclone on daytime sleep and overnight wakefulness in shift workers.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Shift-Work Sleep Disorder
  • Drug: eszopiclone
    3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)
    Other Name: Lunesta
  • Drug: matching placebo
    matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)
    Other Name: placebo
  • Experimental: eszopiclone
    Treatment with eszopiclone
    Intervention: Drug: eszopiclone
  • Placebo Comparator: matching placebo
    Treatment with matching placebo
    Interventions:
    • Drug: eszopiclone
    • Drug: matching placebo
Marino M, Li Y, Pencina MJ, D'Agostino RB Sr, Berkman LF, Buxton OM. Quantifying cardiometabolic risk using modifiable non-self-reported risk factors. Am J Prev Med. 2014 Aug;47(2):131-40. doi: 10.1016/j.amepre.2014.03.006. Epub 2014 Jun 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
February 2010
January 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00900159
ESRC-977
2009-P-000019 ( Other Identifier: Brigham and Women's Hospital )
No
Not Provided
Plan to Share IPD: Undecided
Plan Description: After publication of initial results, would require institutional data sharing agreement with Partners Inc (Brigham and Women's Hospital), and Dr. Buxton
Orfeu M. Buxton, Brigham and Women's Hospital
Brigham and Women's Hospital
  • Sunovion
  • Massachusetts General Hospital
Principal Investigator: Orfeu M Buxton, Ph.D. Brigham and Women's Hospital
Brigham and Women's Hospital
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP