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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: CPAP (continuous positive airway pressure)

• Registration Number: NCT00768807
• Lead Sponsor: Associação Fundo de Incentivo à Pesquisa

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2008-10-06
• Study First Submitted QC: 2008-10-07
• Study First Posted: 2008-10-08
• Study Start: 2009-10
• Primary Completion: 2009-10
• Study Completion: 2010-09
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Apnea-hypopnea index higher than 5 events per hour

Exclusion Criteria

• Body mass index higher than 40 kg/m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP	CPAP (continuous positive airway pressure)	OSA patients submitted to 06 months of CPAP treatment
Sham CPAP	CPAP (continuous positive airway pressure)	Patients submitted to SHAM CPAP use for 06 months

Primary Outcome Measures

Name	Time	Method
Improvement of left ventricular diastolic echo variable	06 months

Trial Locations

Locations (1)

Instituto do Sono/AFIP; 🇧🇷 Sao Paulo, Brazil