Effects of Daytime Eszopiclone Administration in Shift Workers
2 other identifiers
interventional
24
1 country
1
Brief Summary
The purpose of this study is to test the effects of eszopiclone on daytime sleep and overnight wakefulness in shift workers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedFirst Posted
Study publicly available on registry
May 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
August 30, 2017
CompletedAugust 30, 2017
July 1, 2017
8 months
April 13, 2009
March 30, 2017
July 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests
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.
On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
Secondary Outcomes (4)
EEG-recorded Sleep Efficiency
On each treatment, during an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts
Subjective Sleepiness and Performance
On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts
Objective Vigilance Task Performance
On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
Sleep-dependent Memory Consolidation
On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
Study Arms (2)
eszopiclone
EXPERIMENTALTreatment with eszopiclone
matching placebo
PLACEBO COMPARATORTreatment with matching placebo
Interventions
3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)
matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)
Eligibility Criteria
You may qualify if:
- 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 \[IUD\]).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Sumitomo Pharma America, Inc.collaborator
- Massachusetts General Hospitalcollaborator
Study Sites (1)
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
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.
PMID: 24951039DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Orfeu M. Buxton
- Organization
- Brigham and Women's Hospital; Harvard Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
Orfeu M Buxton, Ph.D.
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Orfeu Buxton, Ph.D.
Study Record Dates
First Submitted
April 13, 2009
First Posted
May 12, 2009
Study Start
May 1, 2009
Primary Completion
January 1, 2010
Study Completion
February 1, 2010
Last Updated
August 30, 2017
Results First Posted
August 30, 2017
Record last verified: 2017-07