Effect of Continuous Positive Airway Pressure (CPAP) on Hypertension and Cardiovascular Morbidity-Mortality in Patients With Sleep Apnea and no Daytime Sleepiness
- Conditions
- Sleep ApneaHypertensionCardiovascular Diseases
- Registration Number
- NCT00127348
- Lead Sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 700
- Epworth <10
- Apnea-Hypopnea Index ≥20
- Presence of any chronic disease
- Presence of cardiovascular disease
- Refusal to sign informed consent
- Drug addiction and/or alcoholism
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of hypertension Incidence of cardiovascular events
- Secondary Outcome Measures
Name Time Method Relationship between hypertension and sleep apnea/hypopnea syndrome (SAHS) severity Relationship between cardiovascular events and SAHS severity
Trial Locations
- Locations (1)
Hospital Univ Arnau de Vilanova
🇪🇸Lleida, Catalonia, Spain