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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-P-000019 | Other Identifier | Brigham and Women's Hospital |
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| Name | Class |
|---|---|
| Sumitomo Pharma America, Inc. | INDUSTRY |
| Massachusetts General Hospital | OTHER |
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The purpose of this study is to test the effects of eszopiclone on daytime sleep and overnight wakefulness in shift workers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eszopiclone | Experimental | Treatment with eszopiclone |
|
| matching placebo | Placebo Comparator | Treatment with matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eszopiclone | Drug | 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | On each treatment, during an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Orfeu M Buxton, Ph.D. | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24951039 | Derived | 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. |
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After publication of initial results, would require institutional data sharing agreement with Partners Inc (Brigham and Women's Hospital), and Dr. Buxton
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The recruitment period was from April 2009 to December 2009. All recruitment happened at Brigham and Women's Hospital in Boston, MA. Recruitment included using advertisements around the Boston area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Eszopiclone Then Placebo | Study participants on eszopiclone and then placebo |
| FG001 | Placebo Then Eszopiclone | Study participants on placebo and then eszopiclone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Eszopiclone Then Placebo | Study participants on eszopiclone and then placebo |
| BG001 | Placebo Then Eszopiclone | Study participants on placebo and then eszopiclone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | minutes | On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts |
|
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Adverse events characterized as per clinicaltrials.gov standards. All event were "Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events. "
Systematic methods included regular investigator assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eszopiclone | eszopiclone: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bad taste | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Orfeu M. Buxton | Brigham and Women's Hospital; Harvard Medical School | 617-507-9177 | Orfeu_Buxton@HMS.Harvard.edu |
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| ID | Term |
|---|---|
| D020178 | Sleep Disorders, Circadian Rhythm |
| ID | Term |
|---|---|
| D021081 | Chronobiology Disorders |
| D009422 | Nervous System Diseases |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| matching placebo | Drug | matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab) |
|
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| 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. | On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts |
| 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. | On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts |
| 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. | On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of time sleeping | On each treatment, during an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | units on a scale | On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | milliseconds | On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | words | On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts |
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| 0 |
| 24 |
| 16 |
| 24 |
| EG001 | Placebo | eszopiclone: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab) placebo: matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab) | 0 | 24 | 10 | 24 |
| Headache | General disorders | Systematic Assessment |
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| Dizziness | Cardiac disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Somnolence | Psychiatric disorders | Systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | Systematic Assessment |
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| Chest pain | Cardiac disorders | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
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| Joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in extremities | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Application site dryness | General disorders | Systematic Assessment |
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| Dry eyes | Eye disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Gagging | Gastrointestinal disorders | Systematic Assessment |
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| Head cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hunger | General disorders | Systematic Assessment |
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| Leg cramp | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Listlessness | Psychiatric disorders | Systematic Assessment |
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| Short-term memory loss | Psychiatric disorders | Systematic Assessment |
|
| Tunnel vision | Eye disorders | Systematic Assessment |
|
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| D009784 |
| Occupational Diseases |
| D001523 | Mental Disorders |
| D011725 |
| Pyridines |