Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00400543
Status:
COMPLETED
Last Update Posted:
2006-11-17
First Post:
2006-11-16
Brief Title:
Early Signs of Atherosclerosis in Obstructive Sleep Apnea Effects of Treatment
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Effects of Continuous Positive Airway Pressure CPAP on Early Signs of Atherosclerosis in Patients With Obstructive Sleep Apnea a Randomized Study
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
The purpose of this study is to determine whether CPAP therapy can reverses early signs of atherosclerosis in apparently healthy OSA patients
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None