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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Associacao Fundo de Incentivo a Psicofarmcologia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Associacao Fundo de Incentivo a Psicofarmcologia
ClinicalTrials.gov Identifier:
NCT00768625
First received: October 7, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  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:

MedlinePlus related topics: Obesity Sleep Apnea
U.S. FDA Resources

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

Primary Outcome Measures:
  • Cardiovascular events [ Time Frame: five years ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Associacao Fundo de Incentivo a Psicofarmcologia

Additional 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
Study First Received: October 7, 2008
Last Updated: October 7, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Apnea
Obesity
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013