Left Atrial Volume and Function Evaluation in Patients With Obstructive Sleep Apnea

May 7, 2012 updated by: Associação Fundo de Incentivo à Pesquisa

Left Atrial Volume and 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 left atrial morphology and function evaluated by echocardiography three dimensional

Study Overview

Status

Completed

Conditions

Detailed Description

Several studies have been suggesting that Obstructive Sleep Apnea contributes to deterioration of left ventricular diastolic function . It may lead to atrial myocardium stretching and enlargement which may be associated to increased risk of cardiovascular events. We hypothesized that morphological and functional LA changes might be found using three dimensional echo, and that such alterations are related to obstructive sleep apnea presence.

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

  • Brazil
      • Sao Paulo, Brazil, 04020060
        • Instituto do Sono/Federal University of Sao Paulo

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

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The investigators recruited 56 recently diagnosed OSA patients, confirmed by full polysomnography (PSG), referred to Sleep Laboratory of Psychobiology Department of Federal University of Sao Paulo, Brazil, according to the following inclusion criteria: both genders aging from 29 to 70 years old, with apnea-hypopnea index (AHI) >5 events/hour of sleep. Control group comprised 50 healthy community subjects without OSA confirmed by full PSG, matched by age, gender, and BMI.

Description

Inclusion Criteria:

  • Age from 30 to 70
  • Apnea-hypopnea index > 5 by polysomnography

Exclusion Criteria:

  • Any cardiac disease
  • Poor imaging quality by mean of echocardiography
  • non-sinusal Rhythm

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
A
The subjects for this group are matched for age, gender, body mass index. The presence of obstructive sleep apnea will divide the cohort in 02 subgroups: non-Obstructive Sleep Apnea and Obstructive Sleep Apnea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Left Atrial enlargement
Time Frame: 1 day
1 day

Collaborators and Investigators

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

Sponsor

Associação Fundo de Incentivo à Pesquisa

Investigators

  • Study Director: Sergio Tufik, PhD,MD., Federal University of São Paulo

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

June 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

December 7, 2007

First Submitted That Met QC Criteria

December 7, 2007

First Posted (Estimate)

December 10, 2007

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 7, 2012

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ecoera-001

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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