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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
Information provided by:
Associacao Fundo de Incentivo a Psicofarmcologia Identifier:
First received: October 7, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted

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

Obstructive Sleep Apnea

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.

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

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
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Please refer to this study by its identifier: NCT00768625

Instituto do Sono/AFIP
Sao Paulo, Brazil, 04516001
Sponsors and Collaborators
Associacao Fundo de Incentivo a Psicofarmcologia
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 Identifier (NCT Number):
Responsible Party: Fatima Dumas Cintra, AFIP Identifier: NCT00768625     History of Changes
Other Study ID Numbers: ERA 
Study First Received: October 7, 2008
Last Updated: October 7, 2008

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on February 17, 2017