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NCT00768625 Clinical Trial

Cardiovascular Risk Stratification in Patients With Obstructive Sleep Apnea

Obesity Clinical Trial

— ERA  

Official title:
Cardiovascular Risk Stratification in Patients With Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00768625
Other study ID # ERA
Secondary ID
Status Recruiting
Phase N/A
First received October 7, 2008
Last updated October 7, 2008
Start date April 2005
Est. completion date December 2012

Study information
Verified date October 2008
Source Associacao Fundo de Incentivo a Psicofarmcologia
Contact Fatima D Cintra, MD, PhD
Phone 55 11 99698555
Email fatimacintra@interair.com.br
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date December 2012
Est. primary completion date March 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Body mass index higher than 40

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil Instituto do Sono/AFIP Sao Paulo

Sponsors (1)
Lead Sponsor Collaborator
Associacao Fundo de Incentivo a Psicofarmcologia

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiovascular events five years Yes
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