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Sponsors and Collaborators: |
University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) |
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Information provided by: | University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT00400543 |
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.
Condition | Intervention | Phase |
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Obstructive Sleep Apnea Atherosclerosis |
Device: Continuous positive airway pressure (CPAP) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of Continuous Positive Airway Pressure (CPAP) on Early Signs of Atherosclerosis in Patients With Obstructive Sleep Apnea: a Randomized Study |
Estimated Enrollment: | 24 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | July 2006 |
Obstructive sleep apnea (OSA) is characterized by recurrent episodes of partial or complete obstruction of the upper airway during sleep resulting in oxygen desaturation and arousals from sleep. OSA is recognized as an important public health problem, affecting 9 and 24 % of middle-aged females and males, respectively. There is now compelling evidence that severe OSA is associated with increased cardiovascular morbidity and mortality, mainly due to acute myocardial infarction and stroke. Moreover, the current standard treatment with application of continuous positive airway pressure (CPAP) during the night was associated with decreased non-fatal and fatal cardiovascular events. There are several mechanisms associated with OSA that are potentially harmful to the cardiovascular system, including sympathetic activation, systemic inflammation, production of reactive oxygen species, and endothelial dysfunction. Together, all these factors could contribute to atherosclerosis progression, a key mechanism involved in the genesis of myocardial infarction and stroke. For instance, we recently described the presence of early signs of atherosclerosis in otherwise healthy OSA subjects as characterized by alterations in validated markers of atherosclerosis, including increased arterial stiffness, evaluated by pulse wave velocity (PWV), as well as intima-media thickness (IMT) and carotid diameter (CD). All theses vascular abnormalities correlated significantly with the severity of the OSA. In this study, we will perform a randomized study to evaluate the impact of CPAP therapy on PWV, IMT and CD as well as in catecholamine and C reactive protein. We made the hypothesis that CPAP promotes beneficial effects on atherosclerosis, independent of the other factors, such as blood pressure and cholesterol levels. To this end, we only will study young OSA patients that were free of co-morbidities. Patients will be randomized to no treatment (Control) or CPAP for 4 months. Evalutations will be performed at baseline and after 4 months.
Ages Eligible for Study: | 30 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil | |
Heart Institute (InCor) - University of São Paulo Medical School | |
São Paulo, Brazil, 05403-904 |
Principal Investigator: | Luciano F Drager, MD | Heart Institute (InCor) - University of São Paulo Medical School |
Study ID Numbers: | SDC 2431/04/051 |
Study First Received: | November 16, 2006 |
Last Updated: | November 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00400543 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research |
obstructive sleep apnea arterial stiffness atherosclerosis CPAP heart disease |
Atherosclerosis Arterial Occlusive Diseases Sleep Apnea Syndromes Heart Diseases Apnea Sleep Apnea, Obstructive Respiration Disorders Vascular Diseases |
Dyssomnias Sleep Disorders Arteriosclerosis Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Atherosclerosis Arterial Occlusive Diseases Sleep Apnea Syndromes Apnea Nervous System Diseases Sleep Apnea, Obstructive Respiration Disorders Vascular Diseases |
Sleep Disorders Dyssomnias Arteriosclerosis Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms, Respiratory Cardiovascular Diseases |