Sleep Apnea Clinical Trial
Official title:
Epigenetics Modifications and Subclinical Atherosclerosis in Obstructive Sleep Apnea: The EPIOSA Study
Changes in epigenetic regulation of genes involved in systemic inflammation and metabolic dysfunction in OSA are linked with accelerated cardiovascular morbidity.
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.
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Observational Model: Case Control, Time Perspective: Prospective
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