Cardiovascular Risk Stratification in Patients With Obstructive Sleep Apnea (ERA)

October 7, 2008 updated by: Associacao Fundo de Incentivo a Psicofarmcologia

The purpose of this study is:

  1. To determine the frequency of cardiovascular diseases in patients with OSA, obese, overweight, and lean (BMI<25)
  2. To analyze the CPAP treatment over the clinical evolution of OSA patients
  3. To determine if OSA is a independent predictor of cardiovascular risk

Study Overview

Status

Unknown

Conditions

Detailed Description

Obstructive Sleep Apnea (OSA) is a condition with important cardiovascular repercussions. However, the association between OSA, cardiovascular diseases, and obesity has not been totally clarified. We hypothesized that the cardiovascular consequences of OSA are due to obesity.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

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

Study Contact

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04516001
        • Recruiting
        • Instituto do Sono/AFIP
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fatima D Cintra, MD, PhD

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

1000 OSA patients and 1000 controls enrolled from Instituto do Sono database 500 subjects with body mass index less than 25

Description

Inclusion Criteria:

  • Men and women with OSA (apnea-hypopnea index higher than 5 events/hour)

Exclusion Criteria:

  • Body mass index higher than 40

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular events
Time Frame: five years
five years

Collaborators and Investigators

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

Sponsor

Associacao Fundo de Incentivo a Psicofarmcologia

Investigators

  • Principal Investigator: Fatima D Cintra, PhD, Associacao Fundo de Incentivo a Psicofarmcologia
  • Study Chair: Dalva Poyares, PhD, Associacao Fundo de Incentivo a Psicofarmcologia
  • Study Director: Sergio Tufik, PhD, Associacao Fundo de Incentivo a Psicofarmcologia

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

April 1, 2005

Primary Completion (Anticipated)

March 1, 2011

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

October 7, 2008

First Submitted That Met QC Criteria

October 7, 2008

First Posted (Estimate)

October 8, 2008

Study Record Updates

Last Update Posted (Estimate)

October 8, 2008

Last Update Submitted That Met QC Criteria

October 7, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERA

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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