Clinical trial NCT00900159: Effects of Daytime Eszopiclone Administration in Shift Workers
Official title: Effects of Daytime Eszopiclone Administration in Shift Workers on Overnight Wakefulness During a Subsequent Simulated Nightshift
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shift-Work Sleep Disorder
Keywords: Shift-work
SWSD
eszopiclone
MWT
shiftworkers
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Sumitomo Pharma America, Inc.
name: Massachusetts General Hospital
First posted: 2009-05-12
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests
timeFrame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
Secondary outcomes:
measure: EEG-recorded Sleep Efficiency
timeFrame: On each treatment, during an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts
measure: Subjective Sleepiness and Performance
timeFrame: On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts
measure: Objective Vigilance Task Performance
timeFrame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
measure: Sleep-dependent Memory Consolidation
timeFrame: On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Orfeu M Buxton, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.