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Epigenetics Modifications in Obstructive Sleep Apnea

Epigenetics Modifications and Subclinical Atherosclerosis in Obstructive Sleep Apnea: The EPIOSA Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02131610
Acronym
EPIOSA
Enrollment
350
Registered
2014-05-06
Start date
2013-03-31
Completion date
2019-03-31
Last updated
2014-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea, Snoring

Keywords

Sleep apnea, Obstructive sleep apnea, Subclinical atherosclerosis, Epigenetics, T cells

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.

Interventions

None listed

Sponsors

Instituto Aragones de Ciencias de la Salud
CollaboratorOTHER_GOV
Hospital Miguel Servet
CollaboratorOTHER
Aragon Institute of Health Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Age between 18 to 60

Exclusion criteria

* Any comorbid condition

Design outcomes

Primary

MeasureTime frame
Incidence of cardiovascular events according with or without the presence of epigenetics changes in pro-inflammatory genes5 years

Secondary

MeasureTime frame
biomarkers in blood and urine that correlates with OSA severity which may serve also as markers of disease progression.5 years

Countries

Spain

Contacts

Primary ContactJose M Marin, M.D.
jmmarint@unizar.es+34976765500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026