Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT00460993
Status:
COMPLETED
Last Update Posted:
2014-07-15
First Post:
2007-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'Patricia.Griffiths@va.gov', 'phone': '404-321-6111', 'title': 'Dr. Patricia C. Griffiths', 'phoneExt': '7138', 'organization': 'Atlanta VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Low power to detect statistically significant effects of the interventions on outcomes; Inability to examine predictors of responsiveness because of the small sample size and the large number of predictors of response.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'Active drug given in phase 1, then placebo pill given in phase 2.', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': 'Placebo pill given in phase 1, then active drug give in phase 2. One placebo pill for 6 days.', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sleep Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Active drug given in phase 1, then Placebo pill in phase 2. Lunesta Active drug (eszopiclone) 1 mg during three days of active drug. If sleep efficiency does not improve doses increases to 2 mg for the next three days of active drug administration.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Placebo pill in phase 1, then Active drug given in phase 2. One placebo pill for 6 days'}], 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '18.1', 'upperLimit': '85.2'}, {'value': '65.8', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '83.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 days', 'description': 'Percentage of time in bed at night asleep, averaged over 3 nights, as measured by actigraphy (and by polysomnography in a subgroup of subjects), holding constant time in bed and recording time', 'unitOfMeasure': 'percentage of sleep', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'Active drug during phase 1, then placebo during phase 2. Lunesta Active drug (eszopiclone) 1 mg for 3 days. If sleep efficiency does not improve in 3 three day, dose increases to 2 mg for the next three days of active drug administration.'}, {'id': 'FG001', 'title': 'Group 2', 'description': 'Placebo during phase 1, then active drug phase 2. One placebo for 6 days'}], 'periods': [{'title': 'Phase 1 (6 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Phase 2 (6 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Lunesta Active drug (eszopiclone) 1 mg during 1st week of active drug. If sleep efficiency does not improve does increases to 2 mg for 2nd week of active drug administration.'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'Sugar pill packaged and supplied by Sepracor. One pill weeks one and two of intervention.\n\nWeeks 3 and 4 this Placebo group crosses over to active drug. 1 mg week 3 increasing to 2mg week 4 if sleep efficiency does not improve.'}, {'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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '83.1', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '88.9', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '86.3', 'spread': '7.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sleep Efficiency', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'groupId': 'BG000', 'lowerLimit': '28.2', 'upperLimit': '74.9'}, {'value': '60.7', 'groupId': 'BG001', 'lowerLimit': '12.3', 'upperLimit': '70.8'}, {'value': '59.1', 'groupId': 'BG002', 'lowerLimit': '12.3', 'upperLimit': '74.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'percent of sleep', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': '71 subjects were in baseline. But only 31 subjects enrolled into the study intervention portion used for analysis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-16', 'studyFirstSubmitDate': '2007-04-16', 'resultsFirstSubmitDate': '2013-11-06', 'studyFirstSubmitQcDate': '2007-04-16', 'lastUpdatePostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-16', 'studyFirstPostDateStruct': {'date': '2007-04-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep Efficiency', 'timeFrame': '6 days', 'description': 'Percentage of time in bed at night asleep, averaged over 3 nights, as measured by actigraphy (and by polysomnography in a subgroup of subjects), holding constant time in bed and recording time'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aging', 'Sleep', 'Nursing Home', 'Sleep in nursing homes'], 'conditions': ['Poor Quality Sleep']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effects of the sleep aid Lunesta (Eszopiclone), on older adults who reside in a nursing home and have poor sleep as determined by wrist actigraphy.', 'detailedDescription': "Older people living in nursing homes do not sleep very well for many reasons including pain, sleep disorders like sleep apnea (when someone briefly stops breathing during sleep) and night time urination, as well as the environmental disturbances caused by living in the nursing home, such as noise and disruptive care routines. Previous studies' attempts to improve sleep by modifying the nighttime nursing home environment have shown limited improvements in sleep.\n\nThis study will evaluate how well eszopiclone (Lunesta) works to improve sleep in nursing home residents with poor sleep. Eszopiclone is FDA approved and has been tested on older adults living in the community, but not on older adults living in nursing homes. We expect sleep to improve on the study drug, in comparison to the placebo. Based on adverse events reported in previous samples of older subjects, we expect the study drug to cause very few side effects.\n\nWe will evaluate how well eszopiclone works by measuring sleep at night and during the day. After consenting and final determination of eligibility, participants will complete a baseline phase to assess typical sleep, as well as daytime alertness and activity, thinking, memory and mood. Sleep at night and during the day will be objectively assessed with wrist actigraphs for all subjects. Approximately half will also receive polysomnographic studies to assess nighttime sleep. Subjects who sleep more than 75% of the time they are in bed will not continue in the study. Subjects will be randomized to one of two treatment groups-one will receive the active drug and then a placebo and the other will receive the placebo first and then the active drug. Following randomization, subjects will complete a brief run-in phase and then enter the treatment phase. Assessment of sleep and other measures will be repeated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Nursing Home Patients\n* Age 65 and above\n\nExclusion Criteria:\n\n* Under age 65\n* Anticipated short stay (short term or hospice)\n* Severe behavioral disturbance\n* Unstable drug regimen in prior 2 weeks\n* Use of a hypnotic, antihistamine, benzodiazepine, narcotic or antipsychotic\n\n * once per week in prior 2 weeks\n* Use of a potent inhibitor of CYP3A4\n* Parkinson's with uncontrolled tremor\n* Severe Dementia\n* Severe Sleep Apnea\n* Inability to tolerate wrist Actigraphy\n* Sleep Efficiency \\>75%\n* Sleep apnea\n* Sleep efficiency of greater than 75% during the night."}, 'identificationModule': {'nctId': 'NCT00460993', 'briefTitle': 'Efficacy & Safety of Eszopiclone (Lunesta) in Nursing Home Patients', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Efficacy and Safety of Eszopiclone (Lunesta) in Nursing Home Patients', 'orgStudyIdInfo': {'id': '057-2006'}, 'secondaryIdInfos': [{'id': 'LunestaNH', 'type': 'OTHER', 'domain': 'Sepracor'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Lunesta Active drug (eszopiclone) 1 mg during 1st week of active drug. If sleep efficiency does not improve does increases to 2 mg for 2nd week of active drug administration.', 'interventionNames': ['Drug: Lunesta']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2', 'description': 'Sugar pill packaged and supplied by Sepracor. One pill weeks one and two of intervention.\n\nWeeks 3 and 4 this Placebo group crosses over to active drug. 1 mg week 3 increasing to 2mg week 4 if sleep efficiency does not improve.', 'interventionNames': ['Drug: Lunesta']}], 'interventions': [{'name': 'Lunesta', 'type': 'DRUG', 'otherNames': ['eszopiclone'], 'description': 'Both groups receive eszopiclone. Group 1 receives Lunesta (eszopiclone) in intervention weeks 1 and 2 followed by placebo in weeks 3 and 4.\n\nGroup 2 receives placebo in intervention weeks one and two followed by Lunesta (eszopiclone) in weeks 3 and 4.', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Patricia C Griffiths, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sumitomo Pharma America, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Patricia C Griffiths', 'investigatorAffiliation': 'Emory University'}}}}