Cardiovascular Risk Stratification in Patients With Obstructive Sleep Apnea

NCT ID: NCT00768625

Last Updated: 2008-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2012-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Body mass index higher than 40
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Associacao Fundo de Incentivo a Psicofarmcologia

OTHER

Sponsor Role lead

Responsible Party

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AFIP

Principal Investigators

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Fatima D Cintra, PhD

Role: PRINCIPAL_INVESTIGATOR

Associacao Fundo de Incentivo a Psicofarmcologia

Dalva Poyares, PhD

Role: STUDY_CHAIR

Associacao Fundo de Incentivo a Psicofarmcologia

Sergio Tufik, PhD

Role: STUDY_DIRECTOR

Associacao Fundo de Incentivo a Psicofarmcologia

Locations

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Instituto do Sono/AFIP

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Fatima D Cintra, MD, PhD

Role: CONTACT

Phone: 55 11 99698555

Email: [email protected]

Facility Contacts

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Fatima D Cintra, MD, PhD

Role: primary

Wercules Oliveira

Role: backup

References

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Feres MC, Fonseca FA, Cintra FD, Mello-Fujita L, de Souza AL, De Martino MC, Tufik S, Poyares D. An assessment of oxidized LDL in the lipid profiles of patients with obstructive sleep apnea and its association with both hypertension and dyslipidemia, and the impact of treatment with CPAP. Atherosclerosis. 2015 Aug;241(2):342-9. doi: 10.1016/j.atherosclerosis.2015.05.008. Epub 2015 May 23.

Reference Type DERIVED
PMID: 26071656 (View on PubMed)

Cintra FD, Tufik S, Paola Ad, Feres MC, Melo-Fujita L, Oliveira W, Rizzi C, Poyares D. Cardiovascular profile in patients with obstructive sleep apnea. Arq Bras Cardiol. 2011 Apr;96(4):293-9. doi: 10.1590/s0066-782x2011005000030. Epub 2011 Mar 18. English, Portuguese, Spanish.

Reference Type DERIVED
PMID: 21437515 (View on PubMed)

Rizzi CF, Cintra F, Risso T, Pulz C, Tufik S, de Paola A, Poyares D. Exercise capacity and obstructive sleep apnea in lean subjects. Chest. 2010 Jan;137(1):109-14. doi: 10.1378/chest.09-1201. Epub 2009 Oct 3.

Reference Type DERIVED
PMID: 19801583 (View on PubMed)

Other Identifiers

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ERA

Identifier Type: -

Identifier Source: org_study_id