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

May 4, 2012 updated by: Wercules Antonio Alves de Oliveira, Associação Fundo de Incentivo à Pesquisa
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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04516001
        • Instituto do Sono/AFIP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Apnea-hypopnea index higher than 5 events per hour

Exclusion Criteria:

  • Body mass index higher than 40 kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham CPAP
Patients submitted to SHAM CPAP use for 06 months
Device: CPAP (continuous positive airway pressure)
Patients treated by CPAP for 06 months
Active Comparator: CPAP
OSA patients submitted to 06 months of CPAP treatment
Device: CPAP (continuous positive airway pressure)
Patients treated by CPAP for 06 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of left ventricular diastolic echo variable
Time Frame: 06 months
06 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Associação Fundo de Incentivo à Pesquisa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 6, 2008

First Submitted That Met QC Criteria

October 7, 2008

First Posted (Estimate)

October 8, 2008

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECOera-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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