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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Associacao Fundo de Incentivo a Psicofarmcologia.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00768625
First Posted: October 8, 2008
Last Update Posted: October 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Associacao Fundo de Incentivo a Psicofarmcologia
  Purpose

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

Condition
Obstructive Sleep Apnea Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cardiovascular Risk Stratification in Patients With Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Associacao Fundo de Incentivo a Psicofarmcologia:

Primary Outcome Measures:
  • Cardiovascular events [ Time Frame: five years ]

Estimated Enrollment: 2000
Study Start Date: April 2005
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Body mass index higher than 40
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00768625


Contacts
Contact: Fatima D Cintra, MD, PhD 55 11 99698555 fatimacintra@interair.com.br

Locations
Brazil
Instituto do Sono/AFIP Recruiting
Sao Paulo, Brazil, 04516001
Contact: Fatima D Cintra, MD, PhD    55 11 99698555    fatimacintra@interair.com.br   
Contact: Wercules Oliveira    55 11 50551272    wercules1@hotmail.com   
Principal Investigator: Fatima D Cintra, MD, PhD         
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fatima Dumas Cintra, AFIP
ClinicalTrials.gov Identifier: NCT00768625     History of Changes
Other Study ID Numbers: ERA
First Submitted: October 7, 2008
First Posted: October 8, 2008
Last Update Posted: October 8, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases