Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-28 @ 7:10 PM
Study NCT ID:
NCT01920334
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2013-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Zolpidem CR® in Sleep and Heart Recovery in Cardiac Intensive Care Unit Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D012892', 'term': 'Sleep Deprivation'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-08-08', 'studyFirstSubmitDate': '2013-08-07', 'studyFirstSubmitQcDate': '2013-08-08', 'lastUpdatePostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sleep quality analogue visual scale', 'timeFrame': '3 consecutive mornings', 'description': 'After receiving the drug or placebo at night, the next morning the patients fill in the sleep quality visual analogue scale'}, {'measure': 'The Pittsburgh Sleep Quality Index', 'timeFrame': '1 day, before the intervention', 'description': 'Before the patient receives the drug/placebo, he fills in the Pittsburgh Sleep Quality Index'}, {'measure': 'Epworth Sleepiness Scale', 'timeFrame': '1 day, before the intervention', 'description': 'Before receiving the drug or placebo at night, patients fill in the Epworth Sleepiness Scale'}, {'measure': 'Insomnia Severity Index', 'timeFrame': '1 day, before the intervention', 'description': 'Before receiving the drug or placebo at night, patients fill in the Insomnia Severity Index'}], 'primaryOutcomes': [{'measure': 'Sleep efficiency', 'timeFrame': '1 day - the first night', 'description': 'A full-night polysomnography is conducted in the first night on the ICU'}], 'secondaryOutcomes': [{'measure': 'Troponin T', 'timeFrame': 'Within the first 3 days after an acute coronary syndrome diagnosis', 'description': 'The serum troponin T is measured previously of the intervention and daily for 3 consecutive days'}, {'measure': 'Creatine-kinase MB', 'timeFrame': 'Within the first 3 days after an acute coronary syndrome diagnosis', 'description': 'The serum creatine-kinase MB is measured previously of the intervention and daily for 3 consecutive days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['coronary disease', 'heart diseases', 'enzymes', 'sleep', 'troponin', 'zolpidem'], 'conditions': ['Acute Coronary Syndrome', 'Sleep Deprivation']}, 'descriptionModule': {'briefSummary': 'A double blind, randomized, placebo-controlled study will be conducted in cardiac ICU patients who had been diagnosed with acute coronary syndrome, using a sleep promoting drug (zolpidem controlled release).\n\nThe study hypothesis is that sleeping better can improve the heart recovery in patients with a diagnosis of acute coronary syndrome.', 'detailedDescription': 'The environment of an Intensive Care Unit (ICU) is notoriously inhospitable to patients who experience a period of sleep deprivation (SD). Recent research has shown that SD, even in the short-term, may be related to echo and electrocardiographic changes that may potentially be predictors of cardiac arrhythmias.\n\nThe objective is to evaluate the effects of early treatment with zolpidem controlled release (CR®) compared to a placebo on clinical and polysomnographic parameters for patients in a cardiac ICU who had recently been diagnosed with acute coronary syndrome.\n\nA double blind, randomized, placebo-controlled study will be conducted in cardiac ICU patients who had been diagnosed with acute coronary syndrome. The patients in group A will receive placebo and patients in group B will receive zolpidem CR® 12.5 mg from the first night of hospitalization until their discharge. Patients will undergo overnight full polysomnography on the first night in the ICU and will complete a sleep diary with a visual analogue scale to evaluate sleep quality in the morning after the first 3 nights of hospitalization. The results of the routine ICU laboratory tests including the serum levels of cardiac enzymes \\[troponin T and creatine kinase MB (CK-MB)\\] will be collected preceding the first dose of the drug/placebo, and then daily thereafter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients from 18 to 75 years of age\n* Diagnosis of acute coronary syndrome\n* Capable of swallowing pills\n* Capable of filling in the questionaires\n\nExclusion Criteria:\n\n* Class IV heart failure according to the New York heart association functional class,\n* Patients in a coma\n* Patients receiving mechanical ventilation\n* Patients who regularly use benzodiazepines or other medications for inducing sleep'}, 'identificationModule': {'nctId': 'NCT01920334', 'briefTitle': 'Effects of Zolpidem CR® in Sleep and Heart Recovery in Cardiac Intensive Care Unit Patients', 'organization': {'class': 'OTHER', 'fullName': 'Associação Fundo de Incentivo à Pesquisa'}, 'officialTitle': 'Effects of Zolpidem CR in Sleep and Clinical Outcomes of Patients in Cardiac Intensive Care Unit', 'orgStudyIdInfo': {'id': '1442/11, Ethics Committee'}, 'secondaryIdInfos': [{'id': 'CardioHE, AFIP', 'type': 'OTHER', 'domain': 'AFIP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zolpidem CR 12.5mg', 'description': 'Patients receive zolpidem CR 12.5mg at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital', 'interventionNames': ['Drug: Zolpidem CR 12.5mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients receive placebo at bedtime from the first night on the Cardiac Intensive Care Unit until their discharge from the hospital', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Zolpidem CR 12.5mg', 'type': 'DRUG', 'otherNames': ['Stillnox CR 12.5mg'], 'description': 'Patients will be given zolpidem CR 12.5mg each night for, at least, 3 consecutive nights, including the first night on the Cardiac ICU, when the undergo a full-night polysomnography', 'armGroupLabels': ['Zolpidem CR 12.5mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients will receive placebo pills at night, according to their usual sleep time, from the first night on the Cardiac ICU, until their hospital discharge', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04023062', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Patrick R Burke, MD', 'role': 'CONTACT', 'email': 'doctorburke@hotmail.com', 'phone': '55-11-964288591'}, {'name': 'Aline G Bittencourt, MD', 'role': 'CONTACT', 'email': 'alinebittencourt@hotmail.com', 'phone': '55-11-964287637'}], 'facility': 'Hospital São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Patrick R Burke, MD', 'role': 'CONTACT', 'email': 'doctorburke@hotmail.com', 'phone': '55-11-964288591'}, {'name': 'Dalva R Poyares, MD PhD', 'role': 'CONTACT', 'email': 'poyares@unifesp.br', 'phone': '55-11-21490155'}], 'overallOfficials': [{'name': 'Patrick R Burke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associação Fundo de Incentivo à Pesquisa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Associação Fundo de Incentivo à Pesquisa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Sleep Medicine PhD Student', 'investigatorFullName': 'Patrick Rademaker Burke', 'investigatorAffiliation': 'Associação Fundo de Incentivo à Pesquisa'}}}}