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
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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