Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-28 @ 5:33 PM
Study NCT ID:
NCT00922168
Status:
COMPLETED
Last Update Posted:
2014-02-06
First Post:
2009-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D020182', 'term': 'Sleep Apnea, Central'}, {'id': 'D001049', 'term': 'Apnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-05', 'studyFirstSubmitDate': '2009-06-15', 'studyFirstSubmitQcDate': '2009-06-16', 'lastUpdatePostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Sleep Disordered Breathing in Cardiac Surgery Patients', 'timeFrame': 'September 2009'}], 'secondaryOutcomes': [{'measure': 'Assess Post-Operative Complications of Patients with Sleep Disordered Breathing', 'timeFrame': 'September 2009'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sleep', 'apnea', 'obstructive', 'central'], 'conditions': ['Sleep Disordered Breathing', 'Obstructive Sleep Apnea', 'Central Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'cardiac surgery patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects undergoing major cardiovascular surgery (coronary artery bypass graft, valve replacement surgery, or aortic surgery) under general anesthesia.\n* Subjects in whom surgery is planned for greater than 1 day but less than 60 days from the time of enrollment.\n\nExclusion Criteria:\n\n* Subjects treated for sleep apnea with positive airway pressure (PAP) therapy or oral appliance in the past 30 days.\n* Subjects undergoing Maze procedure for atrial fibrillation.\n* Subjects unable to comply with study procedures.'}, 'identificationModule': {'nctId': 'NCT00922168', 'briefTitle': 'Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cleveland Medical Devices Inc'}, 'officialTitle': 'Pre-operative PSG Assessment of Cardiac Surgery Inpatients', 'orgStudyIdInfo': {'id': 'Pre-op PSG'}, 'secondaryIdInfos': [{'id': 'R44NS042451', 'link': 'https://reporter.nih.gov/quickSearch/R44NS042451', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac Surgeries: CABG, valve replacements'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Hani A Kayyali, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland Medical Devices Inc'}, {'name': 'Nancy Foldvary, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Nancy Collop, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cleveland Medical Devices Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}