search
Back to results

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

Primary Purpose

Hypertension, Sleep Apnea, Obstructive

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CPAP
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring continuous positive airway pressure, hypertension, sleep apnea

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Pronto Socorro Cardiológico de Pernambuco (PROCAPE)
  • Hospital das Clínicas de Porto Alegre
  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
  • Fundação Zerbini - Instituto do Coração (InCor)
  • Hospital Universitário da Universidade de São Paulo (HU)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Continuous positive airway pressure

Nasal strips

Arm Description

Continuous positive airway pressure therapy (CPAP)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Impact of OSA treatment with CPAP on target-organ damage
Impact of OSA treatment with CPAP on vascular parameters (to be published as a sub-study)
Pulse 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)
Validation of portable sleep monitoring to diagnose OSA (to be published as a sub-study)

Full Information

First Posted
October 17, 2014
Last Updated
September 24, 2023
Sponsor
University of Sao Paulo General Hospital
Collaborators
Financiadora de Estudos e Projetos, Conselho Nacional de Desenvolvimento Científico e Tecnológico
search

1. Study Identification

Unique Protocol Identification Number
NCT02270658
Brief Title
Morbidity in Patients With Hypertension and Obstructive Sleep Apnea
Acronym
MORPHEOS
Official Title
Morbidity in Patients With Hypertension and Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Financiadora de Estudos e Projetos, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Sleep Apnea, Obstructive
Keywords
continuous positive airway pressure, hypertension, sleep apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous positive airway pressure
Arm Type
Experimental
Arm Description
Continuous positive airway pressure therapy (CPAP)
Arm Title
Nasal strips
Arm Type
Placebo Comparator
Arm Description
Nasal strips applied to the outside surface of the nose with adhesive.
Intervention Type
Device
Intervention Name(s)
CPAP
Other Intervention Name(s)
Continuous positive airway pressure
Primary Outcome Measure Information:
Title
Impact of OSA treatment with CPAP on office, 24-hour, and central blood pressure (co-primary endpoints).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Impact of OSA treatment with CPAP on target-organ damage
Time Frame
6 months
Title
Impact of OSA treatment with CPAP on vascular parameters (to be published as a sub-study)
Description
Pulse wave velocity and carotid intima-media thickness
Time Frame
6 months
Title
Impact of OSA treatment with CPAP on hypertensive retinopathy and optic nerve damage (to be published as a sub-study)
Time Frame
6 months
Title
Validation of portable sleep monitoring to diagnose OSA (to be published as a sub-study)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geraldo Lorenzi, M.D. PhD
Organizational Affiliation
Fundação Zerbini - Instituto do Coração (InCor)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pronto Socorro Cardiológico de Pernambuco (PROCAPE)
City
Recife
State/Province
PE
ZIP/Postal Code
50100600
Country
Brazil
Facility Name
Hospital das Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035903
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
City
Ribeirão Preto
State/Province
SP
ZIP/Postal Code
14048900
Country
Brazil
Facility Name
Fundação Zerbini - Instituto do Coração (InCor)
City
São Paulo
State/Province
SP
ZIP/Postal Code
054039000
Country
Brazil
Facility Name
Hospital Universitário da Universidade de São Paulo (HU)
City
São Paulo
State/Province
SP
ZIP/Postal Code
05435060
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
34495079
Citation
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.
Results Reference
result

Learn more about this trial

Morbidity in Patients With Hypertension and Obstructive Sleep Apnea

We'll reach out to this number within 24 hrs