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Open Access Highly Accessed Study protocol

Epigenetics modifications and Subclinical Atherosclerosis in Obstructive Sleep Apnea: The EPIOSA study

Jose M Marin12*, Jorge Artal3, Teresa Martin1, Santiago J Carrizo1, Marta Andres2, Inmaculada Martin-Burriel4, Rosa Bolea4, Arianne Sanz4, Luis Varona4, Javier Godino5, Begoña Gallego1, Jose A Garcia-Erce6, Isabel Villar2, Victoria Gil2, Marta Forner2, Jose P Cubero2 and Luis Ros7

Author Affiliations

1 Respiratory Service, Hospital Universitario Miguel Servet, I-3 Avda Isabel la Católica, 50006 Zaragoza, Spain

2 Translational Research Unit, Hospital Universitario Miguel Servet, Zaragoza, Spain

3 Neurology Unit, Hospital Universitario Miguel Servet, Zaragoza, Spain

4 Department of Anatomy, Embriology and Genetics, Faculty of Veterinary, Zaragoza, Spain

5 Cytometry Unit, Instituto Aragonés de Ciencias de la Salud, Zaragoza, Spain

6 Hematology Service, Hospital San Jorge, Huesca, Spain

7 Radiology Department, Hospital Universitario Miguel Servet, Zaragoza, Spain

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BMC Pulmonary Medicine 2014, 14:114  doi:10.1186/1471-2466-14-114

Published: 12 July 2014

Abstract

Background

Obstructive sleep apnea (OSA) is associated with increased risk for cardiovascular morbidity and mortality. Epidemiological and animal models studies generate hypotheses for innovative strategies in OSA management by interfering intermediates mechanisms associated with cardiovascular complications. We have thus initiated the Epigenetics modification in Obstructive Sleep Apnea (EPIOSA) study (ClinicalTrials.gov identifier: NCT02131610).

Methods/design

EPIOSA is a prospective cohort study aiming to recruit 350 participants of caucasian ethnicity and free of other chronic or inflammatory diseases: 300 patients with prevalent OSA and 50 non-OSA subjects. All of them will be follow-up for at least 5 years. Recruitment and study visits are performed in single University-based sleep clinic using standard operating procedures. At baseline and at each one year follow-up examination, patients are subjected to a core phenotyping protocol. This includes a standardized questionnaire and physical examination to determine incident comorbidities and health resources utilization, with a primary focus on cardiovascular events. Confirmatory outcomes information is requested from patient records and the regional Department of Health Services. Every year, OSA status will be assessed by full sleep study and blood samples will be obtained for immediate standard biochemistry, hematology, inflammatory cytokines and cytometry analysis. For biobanking, aliquots of serum, plasma, urine, mRNA and DNA are also obtained. Bilateral carotid echography will be performed to assess subclinical atherosclerosis and atherosclerosis progression. OSA patients are treated according with national guidelines.

Discussion

EPIOSA will enable the prospective evaluation of inflammatory and epigenetics mechanism involved in cardiovascular complication of treated and non-treated patients with OSA compared with non OSA subjects.

Keywords:
Sleep apnea; Subclinical atherosclerosis; Systemic inflammation; Epigenetics