Cardiovascular Risk Stratification in Patients With Obstructive Sleep Apnea

NCT00768625 | Unknown

• 1 other identifier: ERA
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

1. 1.To determine the frequency of cardiovascular diseases in patients with OSA, obese, overweight, and lean (BMI\<25)
2. 2.To analyze the CPAP treatment over the clinical evolution of OSA patients
3. 3.To determine if OSA is a independent predictor of cardiovascular risk

Conditions

Obstructive Sleep Apnea; Obesity

Outcome Measures

Primary Outcomes (1)

• Cardiovascular events

  five years

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Body mass index higher than 40

Sponsors & Collaborators

• Associacao Fundo de Incentivo a Psicofarmcologia: lead

Study Sites (1)

Instituto do Sono/AFIP

São Paulo, São Paulo, 04516001, Brazil

RECRUITING

Related Publications (3)

• 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.

  PMID: 26071656 DERIVED

• 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.

  PMID: 21437515 DERIVED

• 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.

  PMID: 19801583 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fatima D Cintra, PhD

  Associacao Fundo de Incentivo a Psicofarmcologia

  PRINCIPAL INVESTIGATOR

• Dalva Poyares, PhD

  Associacao Fundo de Incentivo a Psicofarmcologia

  STUDY CHAIR

• Sergio Tufik, PhD

  Associacao Fundo de Incentivo a Psicofarmcologia

  STUDY DIRECTOR

Central Study Contacts

Fatima D Cintra, MD, PhD

CONTACT

55 11 99698555; fatimacintra@interair.com.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 8, 2008
• Study Start: April 1, 2005
• Primary Completion: March 1, 2011
• Study Completion: December 1, 2012
• Last Updated: October 8, 2008

Record last verified: 2008-10

Locations

BR (1)