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

Condition Intervention
Shift-Work Sleep Disorder Drug: eszopiclone Drug: matching placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Daytime Eszopiclone Administration in Shift Workers on Overnight Wakefulness During a Subsequent Simulated Nightshift

Resource links provided by NLM:


Further study details as provided by Orfeu M. Buxton, Brigham and Women's Hospital:

Primary Outcome 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 Outcome 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.


Enrollment: 24
Study Start Date: May 2009
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eszopiclone
Treatment with eszopiclone
Drug: eszopiclone
3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)
Other Name: Lunesta
Placebo Comparator: matching placebo
Treatment with matching placebo
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900159


Locations
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Sunovion
Massachusetts General Hospital
Investigators
Principal Investigator: Orfeu M Buxton, Ph.D. Brigham and Women's Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Orfeu M. Buxton, Dr. Orfeu Buxton, Ph.D., Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00900159     History of Changes
Other Study ID Numbers: ESRC-977
2009-P-000019 ( Other Identifier: Brigham and Women's Hospital )
First Submitted: April 13, 2009
First Posted: May 12, 2009
Results First Submitted: March 30, 2017
Results First Posted: August 30, 2017
Last Update Posted: August 30, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
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

Keywords provided by Orfeu M. Buxton, Brigham and Women's Hospital:
Shift-work
SWSD
eszopiclone
MWT
shiftworkers

Additional relevant MeSH terms:
Sleep Wake Disorders
Parasomnias
Sleep Disorders, Circadian Rhythm
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Chronobiology Disorders
Dyssomnias
Occupational Diseases
Eszopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs