HypertensionMORPHEOSNCT02270658
Morbidity in Patients With Hypertension and Obstructive Sleep Apnea
A study testing CPAP in people with Hypertension and Sleep Apnea, Obstructive, run by University of Sao Paulo General Hospital at 5 sites in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Sleep Apnea, Obstructive
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 5 sitesBrazil
- Study dates
- Jan 2015to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥ 90 mm Hg
- Current treatment with at least 1 antihypertensive drug
Who cannot join
- Age <18 and >65 years
- BMI ≥ 40 kg/m2
- Heart failure, EF < 45%, acute myocardial infarction, stroke, significant valvular dysfunction
- Chronic renal failure (serum creatinine > 2 mg/dL)
- Use of cocaine, amphetamines, alcohol, illicit drugs
- Use of sympathomimetics (decongestants, appetite suppressants)
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- Use of oral contraceptives and chronic use of NSAIDs
- Pregnancy
- Secondary causes of hypertension (other than sleep apnea)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
Hospital das Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903
Pronto Socorro Cardiológico de Pernambuco (PROCAPE)
Recife, Pernambuco, 50100600
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, 14048900
Fundação Zerbini - Instituto do Coração (InCor)
São Paulo, São Paulo, 054039000
Hospital Universitário da Universidade de São Paulo (HU)
São Paulo, São Paulo, 05435060
About this study
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.
- Conditions
- Hypertension, Sleep Apnea, Obstructive
- Being tested
- CPAP
- Keywords
- continuous positive airway pressure, hypertension, sleep apnea
- Medical subject headings
- Hypertension, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Also called Continuous positive airway pressure
| Study group | Role | What they receive |
|---|---|---|
| Continuous positive airway pressure | Experimental | Continuous positive airway pressure therapy (CPAP) Receives: Device: CPAP |
| Nasal strips | Placebo comparator | Nasal strips applied to the outside surface of the nose with adhesive. Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of OSA treatment with CPAP on office, 24-hour, and central blood pressure (co-primary endpoints).
Measured: 6 months
Secondary outcomes (4)
Impact of OSA treatment with CPAP on target-organ damage
Measured: 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
Measured: 6 months
Impact of OSA treatment with CPAP on hypertensive retinopathy and optic nerve damage (to be published as a sub-study)
Measured: 6 months
Validation of portable sleep monitoring to diagnose OSA (to be published as a sub-study)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Geraldo Lorenzi Filho, University of Sao Paulo General Hospital
- Investigators
- Geraldo Lorenzi, M.D. PhD, Principal investigator, Fundação Zerbini - Instituto do Coração (InCor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270658
- Sponsor's protocol ID
- 3230/08/146
- Acronym
- MORPHEOS
- Status last verified
- Sep 2023
- First submitted
- 17 Oct 2014
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34495079Lorenzi-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.
PubMed 39879540
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbidity in Patients With Hypertension and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02270658
- Acronym / sponsor ID
- MORPHEOS / 3230/08/146
- Conditions
- Hypertension, Sleep Apnea, Obstructive
- Keywords
- continuous positive airway pressure, hypertension, sleep apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous positive airway pressure | Experimental | Device: CPAPContinuous positive airway pressure therapy (CPAP) |
| Nasal strips | Placebo comparator | Device: CPAPNasal strips applied to the outside surface of the nose with adhesive. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥ 90 mm Hg
- Current treatment with at least 1 antihypertensive drug
Key exclusion criteria (9 listed)
- Age <18 and >65 years
- BMI ≥ 40 kg/m2
- Heart failure, EF < 45%, acute myocardial infarction, stroke, significant valvular dysfunction
- Chronic renal failure (serum creatinine > 2 mg/dL)
- Use of cocaine, amphetamines, alcohol, illicit drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPAlso: Continuous positive airway pressure | Device | Continuous positive airway pressure, Nasal strips |
Primary outcome
Impact of OSA treatment with CPAP on office, 24-hour, and central blood pressure (co-primary endpoints).
Time frame: 6 months
4 secondary outcomes
Impact of OSA treatment with CPAP on target-organ damage
Time frame: 6 months
Impact of OSA treatment with CPAP on vascular parameters (to be published as a sub-study)
Time frame: 6 months
Impact of OSA treatment with CPAP on hypertensive retinopathy and optic nerve damage (to be published as a sub-study)
Time frame: 6 months
Validation of portable sleep monitoring to diagnose OSA (to be published as a sub-study)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Results publication: PubMed 34495079Cruz 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.
- Derived from this study: PubMed 39879540Lorenzi-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geraldo Lorenzi, M.D. PhD principal investigator
Fundação Zerbini - Instituto do Coração (InCor)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Hypertension and Sleep Apnea, Obstructive, run by University of Sao Paulo General Hospital at 5 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of OSA treatment with CPAP on office, 24-hour, and central blood pressure (co-primary endpoints). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02270658, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.