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Effects of Daytime Eszopiclone Administration in Shift Workers

This study has been completed.
Sponsor:
Collaborators:
Sunovion
Massachusetts General Hospital
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00900159
First received: April 13, 2009
Last updated: July 11, 2011
Last verified: July 2011

April 13, 2009
July 11, 2011
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 ] [ Designated as safety issue: No ]
Same as current
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 follwing at least 3 consecutive night shifts ] [ Designated as safety issue: No ]
  • Subjective sleepiness and performance [ Time Frame: On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts ] [ Designated as safety issue: No ]
  • Objective vigilance task performance [ Time Frame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts ] [ Designated as safety issue: No ]
  • Sleep-dependent memory consolidation [ Time Frame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts ] [ Designated as safety issue: No ]
Same as current
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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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)
  • Experimental: eszopiclone
    Intervention: Drug: eszopiclone
  • Placebo Comparator: 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
Both
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00900159
ESRC-977, 2009-P-000019
No
Dr. Orfeu Buxton, Ph.D., 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 2011

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