Epigenetics Modifications in Obstructive Sleep Apnea (EPIOSA)

Aragon Institute of Health Sciences

Status: Unknown

Conditions: Snoring; Sleep Apnea

Study type: Observational

Funder types: Other

Identifiers

NCT02131610

NCT01475421

PI12/02175 (Other Identifier)

Details and patient eligibility

About

Changes in epigenetic regulation of genes involved in systemic inflammation and metabolic dysfunction in OSA are linked with accelerated cardiovascular morbidity.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 18 to 60

Exclusion criteria

• Any comorbid condition

Trial design

350 participants in 2 patient groups

Obstructive slep apnea patients

Description:

Patients with OSA

Control group

Description:

Subjects without OSA