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

Sociedad Española de Neumología y Cirugía Torácica

Status and phase: Completed; Phase 4

Conditions: Hypertension; Cardiovascular Diseases; Sleep Apnea

Treatments: Device: CPAP (Continuous Positive Airway Pressure)

Study type: Interventional

Funder types: Other

Identifiers

NCT00127348

PI 040165

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Epworth <10
• Apnea-Hypopnea Index ≥20

Exclusion criteria

• Presence of any chronic disease
• Presence of cardiovascular disease
• Refusal to sign informed consent
• Drug addiction and/or alcoholism

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)