Structural and Functional Left Ventricular Remodelling in Patients With Obstructive Sleep Apnea

Associação Fundo de Incentivo à Pesquisa

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: CPAP (continuous positive airway pressure)

Study type: Interventional

Funder types: Other

Identifiers

NCT00768807

ECOera-03

Details and patient eligibility

About

The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in left ventricular function and structure after 06 months of continuous positive airway pressure treatment.

Full description

Several studies have been suggesting that Obstructive Sleep Apnea contributes to deterioration of left ventricular diastolic function. It may be associated to increased risk of cardiovascular events. We hypothesized that morphological and functional left ventricular changes might be reverted after treatment with Continuous positive airway pressure.

Enrollment: 450 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Apnea-hypopnea index higher than 5 events per hour

Exclusion criteria

• Body mass index higher than 40 kg/m2

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 2 patient groups

Sham CPAP

Sham Comparator group

Description:

Patients submitted to SHAM CPAP use for 06 months

Treatment:

Device: CPAP (continuous positive airway pressure)

CPAP

Active Comparator group

Description:

OSA patients submitted to 06 months of CPAP treatment

Treatment:

Device: CPAP (continuous positive airway pressure)