Effects of CPAP on Cardiovascular Risk in Obstructive Sleep Apnea (OSA) and Metabolic Syndrome
- Conditions
- Obstructive Sleep ApneaMetabolic Syndrome
- Interventions
- Device: CPAP device - REMstar Plus, Respironics, Murrysville, USA
- Registration Number
- NCT00635674
- Lead Sponsor
- Pavol Jozef Safarik University
- Brief Summary
The increased risk of atherosclerotic morbidity and mortality in patients with obstructive sleep apnea (OSA) has been linked to arterial hypertension, insulin resistance, systemic inflammation, and oxidative stress in previous studies.
We aimed to determine the effects of 8-weeks therapy with continuous positive airway pressure (CPAP) on glucose and lipid profile, systemic inflammation, oxidative stress, and the global cardiovascular disease (CVD) risk in patients with severe OSA and metabolic syndrome.
- Detailed Description
Patients with obstructive sleep apnea (OSA) are at increased risk of atherosclerotic morbidity and mortality.OSA is associated with the development and/or worsening of arterial hypertension, a traditional risk factor of atherosclerosis.Moreover, OSA has been linked to novel factors related to atherogenesis - metabolic syndrome,systemic inflammation,6 and oxidative stress.
Numerous studies have selectively examined the effects of continuous positive airway pressure (CPAP) ventilation, the primary treatment for OSA, on the traditional and novel risk factors of atherosclerosis. A recent metaanalysis of 16 randomized trials indicated that CPAP decreases blood pressure in patients with OSA.9 Furthermore, reductions in serum total cholesterol, C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin (IL)-6 and IL-8 were demonstrated after effective CPAP therapy.In addition, CPAP was shown to reduce systemic oxidative stress.Improvements in insulin sensitivity have been reported in some,but not in all studies. Importantly, substantial evidence links the effects of CPAP to compliance with this treatment.
Most observational studies examined the effects of CPAP across a broad-range of OSA severity, and have included patients with and without the metabolic syndrome. Up to now, no study analyzed the effects of CPAP on glucose and lipid metabolism, systemic inflammation, oxidative stress, and the global cardiovascular disease (CVD) risk within the same cohort of subjects with severe OSA and concurrent metabolic syndrome. Importantly, the metabolic syndrome exacerbates CVD risk over and above that attributable to OSA alone. Therefore, reduction of CVD risk in patients with OSA and concurrent metabolic syndrome is of paramount importance.
The primary purpose of the present study was to determine, in patients with severe OSA and metabolic syndrome compliant to CPAP, the effects of 8-weeks therapy on the glucose and lipid profile, systemic inflammation, oxidative stress, and on the global CVD risk. The secondary goal was to analyze factors related to compliance with CPAP.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- severe OSA (more than 30 obstructive apneas or hypopneas per hour of sleep and excessive daytime sleepiness)
- metabolic syndrome
- endocrine or metabolic disorders other than metabolic syndrome
- history of myocardial infarction, angina or stroke
- inflammatory or other chronic disease
- respiratory disorder other than OSA
- neurological lesions
- regular use of sedative medication or alcohol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group I - compliant CPAP device - REMstar Plus, Respironics, Murrysville, USA CPAP use for more than 4 hr/night Group 2-noncompliant CPAP device - REMstar Plus, Respironics, Murrysville, USA CPAP for less than 4 hr/night
- Primary Outcome Measures
Name Time Method Cardiovascular disease risk profile (as assessed using the multivariable risk factor algorithm) 8 weeks therapy with Continuous positive airway pressure
- Secondary Outcome Measures
Name Time Method insulin sensitivity 8 weeks
Trial Locations
- Locations (1)
Medical Faculty, PJ Safarik University
🇸🇰Kosice, Slovakia