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

University of Sao Paulo General Hospital

Status: Completed

Conditions: Hypertension; Sleep Apnea, Obstructive

Treatments: Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT02270658

3230/08/146

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups, including a placebo group

Continuous positive airway pressure

Experimental group

Description:

Continuous positive airway pressure therapy (CPAP)

Treatment:

Device: CPAP

Nasal strips

Placebo Comparator group

Description:

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

Treatment:

Device: CPAP