Morbidity in Patients With Hypertension and Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Hypertension; Sleep Apnea, Obstructive
• Interventions: Device: CPAP

• Registration Number: NCT02270658
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-10-17
• Study First Posted: 2014-10-21
• Study Start: 2015-01
• Primary Completion: 2020-01
• Study Completion: 2020-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-24
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal strips	CPAP	Nasal strips applied to the outside surface of the nose with adhesive.
Continuous positive airway pressure	CPAP	Continuous positive airway pressure therapy (CPAP)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	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)	6 months
Validation of portable sleep monitoring to diagnose OSA (to be published as a sub-study)	6 months

Trial Locations

Locations (5)

Hospital das Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil

Fundação Zerbini - Instituto do Coração (InCor); 🇧🇷 São Paulo, SP, Brazil

Hospital Universitário da Universidade de São Paulo (HU); 🇧🇷 São Paulo, SP, Brazil

Pronto Socorro Cardiológico de Pernambuco (PROCAPE); 🇧🇷 Recife, PE, Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto; 🇧🇷 Ribeirão Preto, SP, Brazil