Effects of Daytime Eszopiclone Administration in Shift Workers - Full Text View

Sponsor:	Brigham and Women's Hospital
Collaborators:	Sepracor, Inc. Massachusetts General Hospital
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00900159

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:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study
Official Title:	Effects of Daytime Eszopiclone Administration in Shift Workers on Overnight Wakefulness During a Subsequent Simulated Nightshift

Resource links provided by NLM:

MedlinePlus related topics: Sleep Disorders

Drug Information available for: Eszopiclone

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	24
Study Start Date:	May 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
eszopiclone: Experimental	Drug: eszopiclone 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)
matching placebo: Placebo Comparator	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)

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

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900159

Contacts

Contact: Shawn P O'Connor

617-525-6479

Locations

United States, Massachusetts
Brigham & Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Orfeu M Buxton, Ph.D.

Sponsors and Collaborators

Brigham and Women's Hospital

Sepracor, Inc.

Massachusetts General Hospital

Investigators

Principal Investigator:

Orfeu M Buxton, Ph.D.

Brigham and Women's Hospital

More Information

No publications provided

Responsible Party:	Brigham and Women's Hospital ( Dr. Orfeu Buxton, Ph.D. )
Study ID Numbers:	ESRC-977, 2009-P-000019
Study First Received:	April 13, 2009
Last Updated:	January 13, 2010
ClinicalTrials.gov Identifier:	NCT00900159 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

Shift-work
SWSD
eszopiclone
MWT
shiftworkers

Additional relevant MeSH terms:

Signs and Symptoms
Sleep Disorders, Circadian Rhythm
Mental Disorders
Nervous System Diseases
Neurologic Manifestations

Disorders of Environmental Origin
Dyssomnias
Sleep Disorders
Occupational Diseases
Chronobiology Disorders

ClinicalTrials.gov processed this record on February 08, 2010