Obstructive Sleep Apnea in the Absence of Metabolic Syndrome: Pulse Wave Velocity, Inflammatory and Oxidative Stress Markers
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Inflammatory marker (high sensitive C-reactive protein)
Study Overview
Brief Summary
Obstructive Sleep Apnea (OSA) is commonly associated with factors that increase cardiovascular risk, including Metabolic Syndrome (MS). There is a lack of well-controlled clinical studies investigating the independent effects of OSA in the development of cardiovascular disease, especially evaluating jointly mechanisms involved in these disorders such as inflammatory response, oxidative stress and vascular changes. The investigators hypothesized that in the absence of MetS, the mechanisms involved on cardiovascular consequences in OSA patients would be less important.
The purpose of this study is to analyze the effects of OSA in the absence of MS, on inflammatory, oxidative stress and vascular markers; to verify the influence of excessive daytime sleepiness (EDS) on the same parameters; and additionally verify the effects of nasal continuous positive airway pressure (nCPAP)in theses parameters.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •male subjects
- •apnea-hypopnea index > 15/h (OSA group)
- •apnea-hypopnea index < 5/h (control group)
Exclusion Criteria
- •body mass index (BMI) > 30 kg/m2
- •age > 60 years
- •chronic obstructive pulmonary disease
- •cardiac diseases
- •diabetes mellitus
- •metabolic syndrome according to modified National Cholesterol Education Program Adult Treatment Panel III criteria
- •previous OSA treatment
Outcomes
Primary Outcomes
Inflammatory marker (high sensitive C-reactive protein)
Time Frame: 3 months
Oxidative stress marker (homocysteine, cysteine and paraoxonase-1 activity)
Time Frame: 3 months
Arterial stiffness (pulse wave velocity)
Time Frame: 3 months
Angiotensin converting enzyme activity
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Daniela Kuguimoto Andaku Olenscki
Doctoral researcher
Associação Fundo de Incentivo à Pesquisa
