Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-02-28 @ 12:02 AM
Study NCT ID:
NCT02295202
Status:
COMPLETED
Last Update Posted:
2020-06-18
First Post:
2014-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'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': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-17', 'studyFirstSubmitDate': '2014-11-12', 'studyFirstSubmitQcDate': '2014-11-19', 'lastUpdatePostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reversibility of Metabolic Syndrome criteria', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Abdominal fat', 'timeFrame': '6 months', 'description': 'Abdominal CT'}, {'measure': 'Hepatic steatosis', 'timeFrame': '6 months', 'description': 'Abdominal CT'}, {'measure': 'carotid intima-media thickness', 'timeFrame': '6 months', 'description': 'Carotid ultrasound'}, {'measure': 'endothelial function', 'timeFrame': '6 months', 'description': 'Braquial artery ultrasound (flow mediated dilation, %)'}, {'measure': 'coronary atherosclerosis', 'timeFrame': '6 months', 'description': 'Coronary CT'}, {'measure': 'Inflammatory markers', 'timeFrame': '6 months', 'description': 'C-reactive protein'}, {'measure': 'Metabolomics', 'timeFrame': '6 months', 'description': 'Metabolomic analysis (intended to be a sub-study)'}, {'measure': 'MicroRNAs', 'timeFrame': '6 months', 'description': 'MicroRNAs analysis (intended to be a sub-study)'}, {'measure': 'Epicardic fat', 'timeFrame': '6 months', 'description': 'Epicardic fat quantification by CT (intended to be a sub-study)'}, {'measure': 'Heart remodeling', 'timeFrame': '6 months', 'description': 'Evaluated by Tranthoracic echocardiography (intended to be a sub-study)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sleep Apnea', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '35063452', 'type': 'DERIVED', 'citation': 'Giampa SQC, Furlan SF, Freitas LS, Macedo TA, Lebkuchen A, Cardozo KHM, Carvalho VM, Martins FC, Azam IFB, Costa-Hong V, Lopes HF, Baptista ML, Rochitte CE, Bortolotto LA, Lorenzi-Filho G, Drager LF. Effects of CPAP on Metabolic Syndrome in Patients With OSA: A Randomized Trial. Chest. 2022 May;161(5):1370-1381. doi: 10.1016/j.chest.2021.12.669. Epub 2022 Jan 19.'}]}, 'descriptionModule': {'briefSummary': 'Obstructive Sleep Apnea (OSA) is a common condition that may induce hemodynamic and metabolic dysregulation. However, it is not clear if OSA is a mere epiphenomenon or contributes to increase the morbidity associated with metabolic syndrome. This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with metabolic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Metabolic Syndrome (ATP III)\n* Moderate to severe OSA\n\nExclusion Criteria:\n\n* Smokers\n* Patients under chronic use of medications\n* Neurological diseases\n* Coronary artery disease\n* Acute heart failure\n* Chronic renal failure (GFR \\< 30 ml/min)\n* Chronic obstructive pulmonary disease\n* Mild OSA and patients with BMI over 40 kg/m2.'}, 'identificationModule': {'nctId': 'NCT02295202', 'acronym': 'TREATOSA-MS', 'briefTitle': 'Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome: A Randomized Study', 'orgStudyIdInfo': {'id': 'SDC 4075/14/055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPAP', 'description': 'CPAP: Continuous Positive Airway Pressure - Device used for treating OSA during sleep.', 'interventionNames': ['Device: CPAP (REMstar System One Plus - Philips Medical Systems)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Nasal Strips', 'interventionNames': ['Device: Nasal strips']}], 'interventions': [{'name': 'CPAP (REMstar System One Plus - Philips Medical Systems)', 'type': 'DEVICE', 'description': 'Standard device for treating obstructive sleep apnea.', 'armGroupLabels': ['CPAP']}, {'name': 'Nasal strips', 'type': 'DEVICE', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Luciano Drager', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Luciano F Drager, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Institute (InCor), University of Sao Paulo Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fleury', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Luciano F. Drager', 'investigatorFullName': 'Luciano F Drager, MD, PhD', 'investigatorAffiliation': 'University of Sao Paulo'}}}}