Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT03307005
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2017-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Sleep Quality in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077334', 'term': 'Zolpidem'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rnaurora@jhmi.edu', 'phone': '443-513-6535', 'title': 'Rashmi Nisha Aurora, MD, MHS', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '15 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Placebo oral capsule: Placebo capsule one per night taken for 7 nights', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sleep Latency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Participants received seven nights of zolpidem 5 mg'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants received seven nights of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-73.3', 'groupId': 'OG000', 'lowerLimit': '-143', 'upperLimit': '0.2'}, {'value': '21.9', 'groupId': 'OG001', 'lowerLimit': '-5.5', 'upperLimit': '49.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Mean change in sleep latency on second sleep study minus sleep latency on the first sleep study. Lower values suggest faster sleep onset. Sleep latency is measured in minutes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Sleep Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights'}, {'id': 'OG001', 'title': 'Control', 'description': 'Placebo oral capsule: Placebo capsule one per night taken for 7 nights'}], 'classes': [{'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000', 'lowerLimit': '36.5', 'upperLimit': '125.3'}, {'value': '-87.3', 'groupId': 'OG001', 'lowerLimit': '-184.5', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Mean change in total sleep time on second sleep study minus total sleep time on first sleep study. Higher values suggest more total sleep time. Total sleep time is measured in minutes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sleep Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights'}, {'id': 'OG001', 'title': 'Control', 'description': 'Placebo oral capsule: Placebo capsule one per night taken for 7 nights'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '17'}, {'value': '-5.5', 'groupId': 'OG001', 'lowerLimit': '-33', 'upperLimit': '22'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'Mean change in sleep efficiency on second sleep study minus sleep efficiency on the first sleep study. Higher values suggest more efficient sleep. Sleep efficiency is described as a percentage.', 'unitOfMeasure': 'sleep efficiency percentage', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Insomnia Severity Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights'}, {'id': 'OG001', 'title': 'Control', 'description': 'Placebo oral capsule: Placebo capsule one per night taken for 7 nights'}], 'classes': [{'title': 'Baseline ISI score', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '24'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '16'}]}]}, {'title': 'Final ISI score', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '23'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '16'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'a questionnaire that assesses insomnia severity with a range of score from 0-28. Scores \\>=15 are signify the presence of insomnia', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Kansas City Cardiomyopathy Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights'}, {'id': 'OG001', 'title': 'Control', 'description': 'Placebo oral capsule: Placebo capsule one per night taken for 7 nights'}], 'classes': [{'title': 'Baseline KCCQ-23 Score', 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '77', 'upperLimit': '120'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '85', 'upperLimit': '113'}]}]}, {'title': 'Final KCCQ-23 Score', 'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '117'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95', 'upperLimit': '105'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'a validated, disease-specific quality of life measure for patients with heart failure. Raw scores vary from 22-133. Lower scores signify worst heart failure-related quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Epworth Sleepiness Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights'}, {'id': 'OG001', 'title': 'Control', 'description': 'Placebo oral capsule: Placebo capsule one per night taken for 7 nights'}], 'classes': [{'title': 'Baseline ESS score', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '16'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '17'}]}]}, {'title': 'Final ESS score', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '16'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '19'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'a validated questionnaire that assesses chronic subjective sleepiness. The scale ranges from 0-24 with higher values signifying more sleepiness. A binary cutpoint of 11 or higher is considered significant sleepiness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pittsburgh Sleep Quality Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights'}, {'id': 'OG001', 'title': 'Control', 'description': 'Placebo oral capsule: Placebo capsule one per night taken for 7 nights'}], 'classes': [{'title': 'Baseline PSQI score', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '14'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '14'}]}]}, {'title': 'Final PSQI score', 'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '15'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '12'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week', 'description': 'a self report questionnaire that assess sleep quality. The scale ranges from 0-21. Scores higher than 5 indicate poor sleep quality', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zolpidem Tartrate', 'description': 'Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo oral capsule: Placebo capsule one per night taken for 7 nights'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Participants received seven nights of zolpidem 5 mg'}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants received seven nights of placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.3', 'groupId': 'BG000', 'lowerLimit': '43', 'upperLimit': '75'}, {'value': '67.5', 'groupId': 'BG001', 'lowerLimit': '65', 'upperLimit': '70'}, {'value': '63.2', 'groupId': 'BG002', 'lowerLimit': '43', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Persons with heart failure and insomnia'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-27', 'size': 351343, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-10T11:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-site, randomized, parallel, placebo controlled, double blind study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2017-09-28', 'resultsFirstSubmitDate': '2020-01-23', 'studyFirstSubmitQcDate': '2017-10-04', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-10', 'studyFirstPostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Insomnia Severity Index', 'timeFrame': '1 week', 'description': 'a questionnaire that assesses insomnia severity with a range of score from 0-28. Scores \\>=15 are signify the presence of insomnia'}, {'measure': 'Kansas City Cardiomyopathy Questionnaire', 'timeFrame': '1 week', 'description': 'a validated, disease-specific quality of life measure for patients with heart failure. Raw scores vary from 22-133. Lower scores signify worst heart failure-related quality of life.'}, {'measure': 'Epworth Sleepiness Scale', 'timeFrame': '1 week', 'description': 'a validated questionnaire that assesses chronic subjective sleepiness. The scale ranges from 0-24 with higher values signifying more sleepiness. A binary cutpoint of 11 or higher is considered significant sleepiness.'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '1 week', 'description': 'a self report questionnaire that assess sleep quality. The scale ranges from 0-21. Scores higher than 5 indicate poor sleep quality'}], 'primaryOutcomes': [{'measure': 'Sleep Latency', 'timeFrame': '1 week', 'description': 'Mean change in sleep latency on second sleep study minus sleep latency on the first sleep study. Lower values suggest faster sleep onset. Sleep latency is measured in minutes.'}, {'measure': 'Total Sleep Time', 'timeFrame': '1 week', 'description': 'Mean change in total sleep time on second sleep study minus total sleep time on first sleep study. Higher values suggest more total sleep time. Total sleep time is measured in minutes.'}, {'measure': 'Sleep Efficiency', 'timeFrame': '1 week', 'description': 'Mean change in sleep efficiency on second sleep study minus sleep efficiency on the first sleep study. Higher values suggest more efficient sleep. Sleep efficiency is described as a percentage.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Disturbance', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'Poor sleep quality is common in patients with heart failure. The limited available evidence intimates that improving sleep quality in patients with heart failure may improve morbidity and quality of life in this patient population. However, there is a paucity of evidence assessing the use of effective pharmacologic therapies in heart failure. The nonbenzodiazepine, GABA receptor agonist, zolpidem, has been found to have considerable benefits over traditional benzodiazepines as a soporific medication. The investigators hypothesize that zolpidem will safely improve sleep quality in patients with heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21-79 years old\n* HFrEF, EF ≤ 45% (by echocardiography)\n* NYHA functional class I to III\n* Able to give written consent\n* On goal-directed medical therapy for HF, with stable dosing of HF medications for 2 weeks prior to enrollment\n* No hospitalizations for HF within the past month\n* Positive response to experiencing any of the following sleep-related symptoms at least once a week:\n* Difficulty falling asleep\n* Waking up during the night and having difficulty getting back to sleep\n* Waking up too early in the morning and being unable to get back to sleep.\n\nExclusion Criteria:\n\n* Use of sedative-hypnotics, anxiolytic, or benzodiazepines within the previous 2 weeks\n* Current treatment with other sedating medications such as opioids\n* On therapy for pharmacological therapy for depression\n* History of alcohol/drug dependence\n* History of liver disease, HIV, or severe COPD\n* On Thorazine\n* Current use of ketoconazole\n* Current use of tricyclic antidepressants\n* Current use of macrolide antibiotics\n* Current use of anticonvulsant medications\n* Pregnancy. A urine pregnancy test will be performed to exclude pregnancy in potential subjects.'}, 'identificationModule': {'nctId': 'NCT03307005', 'briefTitle': 'Improving Sleep Quality in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Improving Sleep Quality in Heart Failure', 'orgStudyIdInfo': {'id': 'IRB00142395'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Drug: Zolpidem Tartrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Drug: Placebo oral capsule']}], 'interventions': [{'name': 'Zolpidem Tartrate', 'type': 'DRUG', 'description': 'Zolpidem tartrate 5 mg capsule one per night taken for 7 nights', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo oral capsule', 'type': 'DRUG', 'description': 'Placebo capsule one per night taken for 7 nights', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bayview Campus, Asthma and Allergy Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Rashmi Aurora, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}