Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-27 @ 6:13 AM
Study NCT ID:
NCT00900159
Status:
COMPLETED
Last Update Posted:
2017-08-30
First Post:
2009-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Daytime Eszopiclone Administration in Shift Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020178', 'term': 'Sleep Disorders, Circadian Rhythm'}], 'ancestors': [{'id': 'D021081', 'term': 'Chronobiology Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069582', 'term': 'Eszopiclone'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Orfeu_Buxton@HMS.Harvard.edu', 'phone': '617-507-9177', 'title': 'Dr. Orfeu M. Buxton', 'organization': "Brigham and Women's Hospital; Harvard Medical School"}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': '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. "\n\nSystematic methods included regular investigator assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Eszopiclone', 'description': 'eszopiclone: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)', 'otherNumAtRisk': 24, 'otherNumAffected': 16, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'eszopiclone: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)\n\nplacebo: matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)', 'otherNumAtRisk': 24, 'otherNumAffected': 10, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bad taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Application site dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gagging', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Head cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hunger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg cramp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Listlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Short-term memory loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tunnel vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Nighttime Wakefulness Assessed by Mean Sleep Latency Across 4 Maintenance of Wakefulness Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eszopiclone', 'description': 'Medication for insomnia symptoms'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Non-medicated pills'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '22.0'}, {'value': '14.75', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '22.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts', '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.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'EEG-recorded Sleep Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eszopiclone', 'description': 'Medication for insomnia symptoms'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Non-medicated pills'}], 'classes': [{'categories': [{'measurements': [{'value': '92.3', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '88.9', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On each treatment, during an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts', '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.', 'unitOfMeasure': 'percentage of time sleeping', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Sleepiness and Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eszopiclone', 'description': 'Medication for insomnia symptoms'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Non-medicated pills'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Objective Vigilance Task Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eszopiclone', 'description': 'Medication for insomnia symptoms'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Non-medicated pills'}], 'classes': [{'categories': [{'measurements': [{'value': '631', 'spread': '260.5', 'groupId': 'OG000'}, {'value': '617', 'spread': '294.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts', '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.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sleep-dependent Memory Consolidation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eszopiclone', 'description': 'Medication for insomnia symptoms'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Non-medicated pills'}], 'classes': [{'categories': [{'measurements': [{'value': '20.4', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '21.4', 'spread': '6.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts', '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.', 'unitOfMeasure': 'words', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Eszopiclone Then Placebo', 'description': 'Study participants on eszopiclone and then placebo'}, {'id': 'FG001', 'title': 'Placebo Then Eszopiclone', 'description': 'Study participants on placebo and then eszopiclone'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'disempanelled for inappropriate behavior', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "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."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Eszopiclone Then Placebo', 'description': 'Study participants on eszopiclone and then placebo'}, {'id': 'BG001', 'title': 'Placebo Then Eszopiclone', 'description': 'Study participants on placebo and then eszopiclone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-31', 'studyFirstSubmitDate': '2009-04-13', 'resultsFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2009-05-11', 'lastUpdatePostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-31', 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', '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.'}], 'secondaryOutcomes': [{'measure': 'EEG-recorded Sleep Efficiency', 'timeFrame': 'On each treatment, during an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts', '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.'}, {'measure': 'Subjective Sleepiness and Performance', 'timeFrame': 'On each treatment, after an 8.5-hr daytime sleep episode following at least 3 consecutive night shifts', '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.'}, {'measure': 'Objective Vigilance Task Performance', 'timeFrame': 'On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts', '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.'}, {'measure': 'Sleep-dependent Memory Consolidation', 'timeFrame': 'On each treatment, after an 8.5 hour daytime sleep period following at least 3 consecutive night shifts', '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Shift-work', 'SWSD', 'eszopiclone', 'MWT', 'shiftworkers'], 'conditions': ['Shift-Work Sleep Disorder']}, 'referencesModule': {'references': [{'pmid': '24951039', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effects of eszopiclone on daytime sleep and overnight wakefulness in shift workers.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20-50 (men or women)\n* Current shift worker (for at least 3 months, at least 5 overnights/month and 3 consecutive)\n* A willingness and ability to comply with study procedures\n* 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\\]).\n\nExclusion Criteria:\n\n* Current diagnosis of DSM-IV Axis I disorder (other than insomnia)\n* Regular treatment (\\>1time/wk) with CNS-active medication within 1 month of first inpatient visit\n* Uncontrolled medical illness that would interfere with participation in the study\n* BMI\\>32 or \\< 19.8 kg/m2\n* Current symptoms or diagnosis of any moderate to severe sleep disorder other than SWSD\n* Periodic Leg Movement of Sleep Index (PLMSi)\\>20/hr of sleep or Respiratory Desaturation Index (RDI)\\>15 on polysomnography (PSG)\n* Current alcohol or drug dependence/abuse\n* Menopausal or peri-menopausal symptoms that disrupt sleep\n* Pregnant, lactating, or planning to become pregnant\n* Current smoking of more than 10 cigarettes per day\n* Current use of over the counter sleep aids such as Benadryl or melatonin'}, 'identificationModule': {'nctId': 'NCT00900159', 'briefTitle': 'Effects of Daytime Eszopiclone Administration in Shift Workers', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Effects of Daytime Eszopiclone Administration in Shift Workers on Overnight Wakefulness During a Subsequent Simulated Nightshift', 'orgStudyIdInfo': {'id': 'ESRC-977'}, 'secondaryIdInfos': [{'id': '2009-P-000019', 'type': 'OTHER', 'domain': "Brigham and Women's Hospital"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eszopiclone', 'description': 'Treatment with eszopiclone', 'interventionNames': ['Drug: eszopiclone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'matching placebo', 'description': 'Treatment with matching placebo', 'interventionNames': ['Drug: eszopiclone', 'Drug: matching placebo']}], 'interventions': [{'name': 'eszopiclone', 'type': 'DRUG', 'otherNames': ['Lunesta'], 'description': '3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab)', 'armGroupLabels': ['eszopiclone', 'matching placebo']}, {'name': 'matching placebo', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)', 'armGroupLabels': ['matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Orfeu M Buxton, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "After publication of initial results, would require institutional data sharing agreement with Partners Inc (Brigham and Women's Hospital), and Dr. Buxton"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Sumitomo Pharma America, Inc.', 'class': 'INDUSTRY'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Orfeu Buxton, Ph.D.', 'investigatorFullName': 'Orfeu M. Buxton', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}