Morbidity in Patients With Hypertension and Obstructive Sleep Apnea (MORPHEOS)

September 24, 2023 updated by: Geraldo Lorenzi Filho, University of Sao Paulo General Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • PE
      • Recife, PE, Brazil, 50100600
        • Pronto Socorro Cardiológico de Pernambuco (PROCAPE)
    • RS
      • Porto Alegre, RS, Brazil, 90035903
        • Hospital das Clinicas de Porto Alegre
    • SP
      • Ribeirão Preto, SP, Brazil, 14048900
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
      • São Paulo, SP, Brazil, 054039000
        • Fundação Zerbini - Instituto do Coração (InCor)
      • São Paulo, SP, Brazil, 05435060
        • Hospital Universitário da Universidade de São Paulo (HU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous positive airway pressure
Continuous positive airway pressure therapy (CPAP)
Device: CPAP
Other Names:
  • Continuous positive airway pressure
Placebo Comparator: Nasal strips
Nasal strips applied to the outside surface of the nose with adhesive.
Device: CPAP
Other Names:
  • Continuous positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Impact of OSA treatment with CPAP on office, 24-hour, and central blood pressure (co-primary endpoints).
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of OSA treatment with CPAP on target-organ damage
Time Frame: 6 months
6 months
Impact of OSA treatment with CPAP on vascular parameters (to be published as a sub-study)
Time Frame: 6 months
Pulse wave velocity and carotid intima-media thickness
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
6 months
Validation of portable sleep monitoring to diagnose OSA (to be published as a sub-study)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Financiadora de Estudos e Projetos
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Geraldo Lorenzi, M.D. PhD, Fundação Zerbini - Instituto do Coração (InCor)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

October 17, 2014

First Posted (Estimated)

October 21, 2014

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 24, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3230/08/146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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