Effect of Continuous Positive Airway Pressure (CPAP) on Hypertension and Cardiovascular Morbidity-Mortality in Patients With Sleep Apnea and no Daytime Sleepiness

NCT00127348 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2007-04-04

No results posted yet for this study

Summary

The objective of the study is to evaluate the effect of CPAP over the incidence of cardiovascular events and diagnosis of arterial hypertension in patients with sleep apnea.

The hypothesis of the study is the following: The existence of sleep disordered breathing in the general population is associated to an increased incidence of arterial hypertension and to an increased risk of suffering cardiovascular disease. CPAP corrects respiratory disorders during sleep. Treatment with CPAP in subjects with sleep disordered breathing without daytime sleepiness reduces the incidence of systemic arterial hypertension and cardiovascular complications.

The end points of the study are new diagnosis of arterial hypertension and new cardiovascular events.

All patients, after randomization, will be followed for three years.

Conditions

Interventions

DEVICE

CPAP (Continuous Positive Airway Pressure)

Sponsors & Collaborators

  • Sociedad Española de Neumología y Cirugía Torácica

    lead OTHER

Principal Investigators

  • Ferran Barbe, MD · Hospital Universitari Arnau de Vilanova. Lleida. Spain

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Completion
2006-04-30

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00127348 on ClinicalTrials.gov