Right Ventricular Function in Patients With Obstructive Sleep Apnea

Right Ventricular Function in Patients With Obstructive Sleep Apnea Assessed by Real-time Three-dimensional Echocardiography

The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in right ventricular function evaluated by three dimensional echocardiography.

Study Overview

Status

Completed

Detailed Description

Several studies have reported the association between sleep disorders to an increased risk to the development of cardiac disease. However, there is no substantial that about the influence of Obstructive Sleep Apnea on the right ventricular function. Objective: to analyse the right ventricular function in patients with Obstructive Sleep Apnea by means of Real-Time Three dimensional Echocardiography.

Study Type

Observational

Enrollment (Actual)

106

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

      • Sao Paulo, Brazil, 04516001
        • Escola Paulista de Medicina

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Initially, 56 patients with obstructive sleep apnea (OSA) and 50 non-OSA controls underwent real-time three-dimensional echocardiography. 30 Patients with moderate and severe OSA underwent to continuous positive airway pressure treatment over 6 months. Echocardiogram will be repeated on the third and sixth months from the treatment onset.

Description

Inclusion Criteria:

  • Individuals > 18 years old and < 70.

Exclusion Criteria:

  • Body mass index greater than 35
  • Past of clinically significant cardiac conditions

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

Cohorts and Interventions

Group / Cohort
Group 1 - Obstructive Sleep Apnea (OSA)
Fifty-six patients with Obstructive Sleep Apnea
Group 2 - Non-OSA Controls
Fifty individuals without OSA with similar age, gender and body mass index (BMI)
Group 3 - Treatment
Fifteen patients with moderate and severe sleep apnea from group 1 underwent treatment with continuous positive airway pressure
Group 4 - Placebo
Fifteen patients with moderate/severe sleep apnea underwent to placebo

Collaborators and Investigators

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

Investigators

  • Study Director: Orlando Campos, PhD, Escola Paulista de Medicina

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

June 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 13, 2010

First Submitted That Met QC Criteria

September 13, 2010

First Posted (Estimate)

September 14, 2010

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 7, 2012

Last Verified

June 1, 2010

More Information

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.

Clinical Trials on Obstructive Sleep Apnea

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