Efficacy of PAP Therapy on Blood Pressure

University of Crete

Status: Completed

Conditions: Obstructive Sleep Apnoea

Treatments: Device: positive airway pressure (PAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT02417584

PAPBP-01

Details and patient eligibility

About

The aim of the study was to determine the long term effects of compliance with positive airway pressure therapy on blood pressure in both hypertensive and normotensive patients with obstructive sleep apnoea hypopnoea syndrome.

Full description

Scientific data about the causal role of obstructive sleep apnoea hypopnoea syndrome (OSAHS) in the development of systemic hypertension and the effects of positive airway pressure (PAP) treatment on blood pressure (BP) control are continuously increasing; however they are controversial. We aimed to determine the long term effects of compliance with PAP therapy on BP in both hypertensive and normotensive patients with OSAHS.

Enrollment: 1,168 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• newly diagnosed OSAHS by polysomnography according to standard criteria
• no history of previous PAP therapy
• normotensive and hypertensive patients
• an above-elementary school education.

Exclusion criteria

• refusal to participate
• refusal of PAP therapy
• secondary hypertension
• central sleep apnea syndromes
• obesity hypoventilation syndrome
• restrictive ventilator syndromes
• history of established cardiovascular disease
• severe congestive heart failure
• a history of life-threatening arrhythmias
• severe cardiomyopathy
• significant chronic kidney disease
• long-term oxygen therapy
• family or personal history of mental illness
• drug or alcohol abuse
• severe cognitive impairment
• concurrent oncological diseases
• need for chronic use of medication that may affect BP levels
• pregnancy
• history of narcolepsy or restless leg syndrome

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,168 participants in 1 patient group

positive airway pressure (PAP)

Experimental group

Description:

Treatment with positive airway pressure (PAP)

Treatment:

Device: positive airway pressure (PAP)