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Morbidity in Patients With Hypertension and Obstructive Sleep Apnea

Morbidity in Patients With Hypertension and Obstructive Sleep Apnea

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02270658
Acronym
MORPHEOS
Enrollment
123
Registered
2014-10-21
Start date
2015-01-31
Completion date
2020-12-31
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Sleep Apnea, Obstructive

Keywords

continuous positive airway pressure, hypertension, sleep apnea

Brief 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.

Interventions

DEVICECPAP

Sponsors

Financiadora de Estudos e Projetos
CollaboratorOTHER
Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥ 90 mm Hg * Current treatment with at least 1 antihypertensive drug

Exclusion criteria

* 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) * Use of oral contraceptives and chronic use of NSAIDs * Pregnancy * Secondary causes of hypertension (other than sleep apnea)

Design outcomes

Primary

MeasureTime frame
Impact of OSA treatment with CPAP on office, 24-hour, and central blood pressure (co-primary endpoints).6 months

Secondary

MeasureTime frameDescription
Impact of OSA treatment with CPAP on target-organ damage6 months
Impact of OSA treatment with CPAP on vascular parameters (to be published as a sub-study)6 monthsPulse wave velocity and carotid intima-media thickness
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026