Back to resultsEffects of Daytime Eszopiclone Administration in Shift Workers
Primary Purpose
Shift-Work Sleep Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eszopiclone
matching placebo
Sponsored by
About this trial
This is an interventional treatment trial for Shift-Work Sleep Disorder focused on measuring Shift-work, SWSD, eszopiclone, MWT, shiftworkers
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
Sites / Locations
- Brigham & Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
eszopiclone
matching placebo
Arm Description
Treatment with eszopiclone
Treatment with matching placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
EEG-recorded Sleep Efficiency
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
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
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
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.
Full Information
NCT ID
NCT00900159
First Posted
April 13, 2009
Last Updated
July 31, 2017
Sponsor
Brigham and Women's Hospital
Collaborators
Sumitomo Pharma America, Inc., Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00900159
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Sumitomo Pharma America, Inc., Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shift-Work Sleep Disorder
Keywords
Shift-work, SWSD, eszopiclone, MWT, shiftworkers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eszopiclone
Arm Type
Experimental
Arm Description
Treatment with eszopiclone
Arm Title
matching placebo
Arm Type
Placebo Comparator
Arm Description
Treatment with matching placebo
Intervention Type
Drug
Intervention Name(s)
eszopiclone
Other Intervention Name(s)
Lunesta
Intervention Description
3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)
Intervention Type
Drug
Intervention Name(s)
matching placebo
Other Intervention Name(s)
placebo
Intervention Description
matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)
Primary Outcome Measure Information:
Title
Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests
Description
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.
Time Frame
On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
Secondary Outcome Measure Information:
Title
EEG-recorded Sleep Efficiency
Description
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.
Time Frame
On each treatment, during an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts
Title
Subjective Sleepiness and Performance
Description
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.
Time Frame
On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts
Title
Objective Vigilance Task Performance
Description
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.
Time Frame
On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
Title
Sleep-dependent Memory Consolidation
Description
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.
Time Frame
On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orfeu M Buxton, Ph.D.
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
After publication of initial results, would require institutional data sharing agreement with Partners Inc (Brigham and Women's Hospital), and Dr. Buxton
Citations:
PubMed Identifier
24951039
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.
Results Reference
derived
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Effects of Daytime Eszopiclone Administration in Shift Workers
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