Status:
COMPLETED
Effects of Daytime Eszopiclone Administration in Shift Workers
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Massachusetts General Hospital
Conditions:
Shift-Work Sleep Disorder
Eligibility:
All Genders
20-50 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00900159
Start Date
May 1 2009
End Date
February 1 2010
Last Update
August 30 2017
Active Locations (1)
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1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115