Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT02270658
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2014-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Morbidity in Patients With Hypertension and Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-24', 'studyFirstSubmitDate': '2014-10-17', 'studyFirstSubmitQcDate': '2014-10-17', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of OSA treatment with CPAP on office, 24-hour, and central blood pressure (co-primary endpoints).', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Impact of OSA treatment with CPAP on target-organ damage', 'timeFrame': '6 months'}, {'measure': 'Impact of OSA treatment with CPAP on vascular parameters (to be published as a sub-study)', 'timeFrame': '6 months', 'description': 'Pulse wave velocity and carotid intima-media thickness'}, {'measure': 'Impact of OSA treatment with CPAP on hypertensive retinopathy and optic nerve damage (to be published as a sub-study)', 'timeFrame': '6 months'}, {'measure': 'Validation of portable sleep monitoring to diagnose OSA (to be published as a sub-study)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['continuous positive airway pressure', 'hypertension', 'sleep apnea'], 'conditions': ['Hypertension', 'Sleep Apnea, Obstructive']}, 'referencesModule': {'references': [{'pmid': '34495079', 'type': 'RESULT', 'citation': 'Cruz FCSG, Drager LF, Queiroz DBC, Souza GA, Pedrosa RP, Patriota TLGC, Dorea EL, Vieira MLC, Righi CG, Martinez D, Silva GAD, Silva GV, Pio-Abreu A, Lotufo PA, Benseaor IM, Bortolotto LA, Fuchs FD, Lorenzi-Filho G. The effect of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea and uncontrolled hypertension - Study design and challenges during the COVID-19 pandemic. Clinics (Sao Paulo). 2021 Sep 3;76:e2926. doi: 10.6061/clinics/2021/e2926. eCollection 2021.'}, {'pmid': '39879540', 'type': 'DERIVED', 'citation': 'Lorenzi-Filho G, Cruz FCSG, Queiroz DBC, Vieira MLC, Pedrosa RP, Couto Patriota TLG, Righi CG, Martinez D, da Silva GA, Silva GV, Pio-Abreu A, Cabrini ML, Giampa SQC, Dorea EL, Lotufo PA, Bensenor IM, Bortolotto LA, Fuchs FD, Drager LF. Effects of Continuous Positive Airway Pressure on Central and Peripheral Blood Pressure in Patients with Uncontrolled Hypertension and Obstructive Sleep Apnea: The Randomized Controlled MORPHEOS Clinical Trial. Ann Am Thorac Soc. 2025 May;22(5):757-767. doi: 10.1513/AnnalsATS.202407-688OC.'}]}, 'descriptionModule': {'briefSummary': 'MORPHEOS is a multicenter, randomized, unblinded study, for patients diagnosed with uncontrolled hypertension and at least one antihypertensive medication. Those patients with significant sleep apnea wil be randomized to CPAP or nasal strips for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥ 90 mm Hg\n* Current treatment with at least 1 antihypertensive drug\n\nExclusion Criteria:\n\n* Age \\<18 and \\>65 years\n* BMI ≥ 40 kg/m2\n* Heart failure, EF \\< 45%, acute myocardial infarction, stroke, significant valvular dysfunction\n* Chronic renal failure (serum creatinine \\> 2 mg/dL)\n* Use of cocaine, amphetamines, alcohol, illicit drugs\n* Use of sympathomimetics (decongestants, appetite suppressants)\n* Use of oral contraceptives and chronic use of NSAIDs\n* Pregnancy\n* Secondary causes of hypertension (other than sleep apnea)'}, 'identificationModule': {'nctId': 'NCT02270658', 'acronym': 'MORPHEOS', 'briefTitle': 'Morbidity in Patients With Hypertension and Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Morbidity in Patients With Hypertension and Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': '3230/08/146'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous positive airway pressure', 'description': 'Continuous positive airway pressure therapy (CPAP)', 'interventionNames': ['Device: CPAP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nasal strips', 'description': 'Nasal strips applied to the outside surface of the nose with adhesive.', 'interventionNames': ['Device: CPAP']}], 'interventions': [{'name': 'CPAP', 'type': 'DEVICE', 'otherNames': ['Continuous positive airway pressure'], 'armGroupLabels': ['Continuous positive airway pressure', 'Nasal strips']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50100600', 'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Pronto Socorro Cardiológico de Pernambuco (PROCAPE)', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'zip': '90035903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital das Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '14048900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '054039000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Fundação Zerbini - Instituto do Coração (InCor)', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05435060', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Universitário da Universidade de São Paulo (HU)', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Geraldo Lorenzi, M.D. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundação Zerbini - Instituto do Coração (InCor)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Financiadora de Estudos e Projetos', 'class': 'OTHER'}, {'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Geraldo Lorenzi Filho', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}