Early Signs of Atherosclerosis in Obstructive Sleep Apnea: Effects of Treatment

NCT00400543 | Completed Phase 4

• 1 other identifier: SDC 2431/04/051
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is associated with adverse cardiovascular outcomes, including acute myocardial infarction and stroke. Atherosclerosis is an important step for these events. Recent studies demonstrated the independent association between OSA and validated markers of atherosclerosis. However, the impact of treatment with continuous positive airway pressure (CPAP) on these markers is unknown. The purpose of this study is to determine whether CPAP therapy can reverses early signs of atherosclerosis in apparently healthy OSA patients.

Conditions

Obstructive Sleep Apnea; Atherosclerosis

Keywords

obstructive sleep apnea; arterial stiffness; atherosclerosis; CPAP; heart disease

Outcome Measures

Primary Outcomes (3)

• Arterial stiffness (evaluated by PWV)

• Intima media thickness (IMT)

• Carotid diameter (CD)

Secondary Outcomes (3)

• 24h blood pressure monitoring

• plasma catecholamine

• C-reactive protein (CRP)

Interventions

Continuous positive airway pressure (CPAP) DEVICE

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males with recent sleep study (\<1 month) showing severe obstructive sleep apnea, defined as at least 30 events of apnea and hypopnea per hour of sleep.

You may not qualify if:

• Age \>60 years old, body mass index (BMI) \>35 kg/m2, diabetes mellitus, hypertension, cerebrovascular, aortic, heart, and valvar heart diseases, renal failure, arrhythmias, smoking habit, and chronic use of medications, including statins.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Heart Institute (InCor) - University of São Paulo Medical School

São Paulo, São Paulo, 05403-904, Brazil

Location

Related Publications (1)

• Drager LF, Bortolotto LA, Figueiredo AC, Krieger EM, Lorenzi GF. Effects of continuous positive airway pressure on early signs of atherosclerosis in obstructive sleep apnea. Am J Respir Crit Care Med. 2007 Oct 1;176(7):706-12. doi: 10.1164/rccm.200703-500OC. Epub 2007 Jun 7.

  PMID: 17556718 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Atherosclerosis; Heart Diseases

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Luciano F Drager, MD

  InCor Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 17, 2006
• Study Start: January 1, 2004
• Study Completion: July 1, 2006
• Last Updated: November 17, 2006

Record last verified: 2006-11

Locations

BR (1)