Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Financiadora de Estudos e Projetos | OTHER |
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous positive airway pressure | Experimental | Continuous positive airway pressure therapy (CPAP) |
|
| Nasal strips | Placebo Comparator | Nasal strips applied to the outside surface of the nose with adhesive. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Impact of OSA treatment with CPAP on office, 24-hour, and central blood pressure (co-primary endpoints). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of OSA treatment with CPAP on target-organ damage | 6 months | |
| Impact of OSA treatment with CPAP on vascular parameters (to be published as a sub-study) | Pulse wave velocity and carotid intima-media thickness |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Geraldo Lorenzi, M.D. PhD | Fundação Zerbini - Instituto do Coração (InCor) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pronto Socorro Cardiológico de Pernambuco (PROCAPE) | Recife | Pernambuco | 50100600 | Brazil | ||
| Hospital das Clínicas de Porto Alegre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34495079 | Result | 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. | |
| 39879540 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 months |
| Impact of OSA treatment with CPAP on hypertensive retinopathy and optic nerve damage (to be published as a sub-study) | 6 months |
| Validation of portable sleep monitoring to diagnose OSA (to be published as a sub-study) | 6 months |
| Porto Alegre |
| Rio Grande do Sul |
| 90035903 |
| Brazil |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto | Ribeirão Preto | São Paulo | 14048900 | Brazil |
| Fundação Zerbini - Instituto do Coração (InCor) | São Paulo | São Paulo | 054039000 | Brazil |
| Hospital Universitário da Universidade de São Paulo (HU) | São Paulo | São Paulo | 05435060 | Brazil |
| Derived |
| 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. |
| D012140 |
| Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |