Epigenetics Modifications in Obstructive Sleep Apnea
- Conditions
- Sleep ApneaSnoring
- Registration Number
- NCT02131610
- Lead Sponsor
- Aragon Institute of Health Sciences
- Brief Summary
Changes in epigenetic regulation of genes involved in systemic inflammation and metabolic dysfunction in OSA are linked with accelerated cardiovascular morbidity.
- Detailed Description
Design. EPIOSA is a 5-yr non-interventional longitudinal prospective study being conducted at the Sleep Clinic of the Hospital Miguel Servet, a large teaching hospital in Zaragoza (Spain). Following a baseline visit, subjects are to be followed-up at 3 months, and then every year.
Subject participation. The investigators will enroll a total 300 consecutive OSA male patients aged 20-60 yrs, with baseline apnea-hypopnea index ≥ 5 events per hour of sleep (AHI). In addition, 50 control subjects (AHI \< 5) aged 20-60 yrs and matched by body mass index (BMI) are also to be recruited. Exclusion criteria will include any comorbid condition including alcohol and tobacco use.
Measurements: Routine clinical assessment, full sleep study, bilateral carotid ultrasonography, biochemistry, circulating inflammatory cytokines, T cell subsets and epigenetics studies at baseline and every year until at least 5 years of follow-up.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 350
- Age between 18 to 60
- Any comorbid condition
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of cardiovascular events according with or without the presence of epigenetics changes in pro-inflammatory genes 5 years
- Secondary Outcome Measures
Name Time Method biomarkers in blood and urine that correlates with OSA severity which may serve also as markers of disease progression. 5 years
Trial Locations
- Locations (1)
Hospital Miguel Servet
🇪🇸Zaragoza, Spain