Epigenetics Modifications in Obstructive Sleep Apnea (EPIOSA)
Changes in epigenetic regulation of genes involved in systemic inflammation and metabolic dysfunction in OSA are linked with accelerated cardiovascular morbidity.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration:||5 Years|
|Official Title:||Epigenetics Modifications and Subclinical Atherosclerosis in Obstructive Sleep Apnea: The EPIOSA Study|
- Incidence of cardiovascular events according with or without the presence of epigenetics changes in pro-inflammatory genes [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- biomarkers in blood and urine that correlates with OSA severity which may serve also as markers of disease progression. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
serum and plasma samples.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2019|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
Obstructive slep apnea patients
Patients with OSA
Subjects without OSA
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02131610
|Contact: Jose M Marin, M.D.||+firstname.lastname@example.org|
|Hospital Miguel Servet||Recruiting|
|Zaragoza, Spain, 50009|
|Contact: Jose M Marin, M.D. +34 976765500 ext 1941 email@example.com|
|Sub-Investigator: Maria T Martin, M.D.|
|Principal Investigator: Jose M Marin, M.D.|
|Principal Investigator:||Jose M Marin, M.D.||Hospital Universitario Miguel Servet|