Efficacy of PAP Therapy on Blood Pressure

University of Crete1,168 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,168

Conditions

Obstructive Sleep Apnoea

Interventions

positive airway pressure (PAP)DEVICE

Positive Airway Pressure (PAP) is a non-invasive machine providing air pressure f to prevent the collapse of the oropharyngeal walls and the obstruction of airflow during sleep, which occurs in obstructive sleep apnea hypopnea syndrome.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Sleep Disorders Center, Department of Thoracic Medicine, University of Crete,

Heraklion, Greece

Outcomes

Primary Outcomes

drop in blood pressure

Time frame: two years

Data from ClinicalTrials.gov

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