Morbidity in Patients With Hypertension and Obstructive Sleep Apnea

NCT02270658 | Completed DMC

• 1 other identifier: 3230/08/146
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 5

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.

Conditions

Hypertension; Sleep Apnea, Obstructive

Keywords

continuous positive airway pressure; hypertension; sleep apnea

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (4)

• 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)

  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

Study Arms (2)

Continuous positive airway pressure

EXPERIMENTAL

Continuous positive airway pressure therapy (CPAP)

Device: CPAP

Nasal strips

PLACEBO COMPARATOR

Nasal strips applied to the outside surface of the nose with adhesive.

Device: CPAP

Interventions

CPAP DEVICE

Also known as: Continuous positive airway pressure

Continuous positive airway pressure; Nasal strips

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Financiadora de Estudos e Projetos: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (5)

Pronto Socorro Cardiológico de Pernambuco (PROCAPE)

Recife, Pernambuco, 50100600, Brazil

Location

Hospital das Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, São Paulo, 14048900, Brazil

Location

Fundação Zerbini - Instituto do Coração (InCor)

São Paulo, São Paulo, 054039000, Brazil

Location

Hospital Universitário da Universidade de São Paulo (HU)

São Paulo, São Paulo, 05435060, Brazil

Location

Related Publications (2)

• 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: 34495079 RESULT

• 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.

  PMID: 39879540 DERIVED

MeSH Terms

Conditions

Hypertension; Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Geraldo Lorenzi, M.D. PhD

  Fundação Zerbini - Instituto do Coração (InCor)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 21, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

BR (5)