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Epigenetics Modifications in Obstructive Sleep Apnea (EPIOSA)

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ClinicalTrials.gov Identifier: NCT02131610
Recruitment Status : Recruiting
First Posted : May 6, 2014
Last Update Posted : May 6, 2014
Sponsor:
Collaborators:
Instituto Aragones de Ciencias de la Salud
Hospital Miguel Servet
Information provided by (Responsible Party):
Aragon Institute of Health Sciences

April 16, 2014
May 6, 2014
May 6, 2014
March 2013
March 2018   (Final data collection date for primary outcome measure)
Incidence of cardiovascular events according with or without the presence of epigenetics changes in pro-inflammatory genes [ Time Frame: 5 years ]
Same as current
No Changes Posted
biomarkers in blood and urine that correlates with OSA severity which may serve also as markers of disease progression. [ Time Frame: 5 years ]
Same as current
Not Provided
Not Provided
 
Epigenetics Modifications in Obstructive Sleep Apnea
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.

Observational [Patient Registry]
Observational Model: Case Control
Time Perspective: Prospective
5 Years
Retention:   Samples Without DNA
Description:
serum and plasma samples.
Non-Probability Sample
Subjects that will be study because suspected OSA
  • Sleep Apnea
  • Snoring
Not Provided
  • Obstructive slep apnea patients
    Patients with OSA
  • Control group
    Subjects without OSA
Marin JM, Artal J, Martin T, Carrizo SJ, Andres M, Martin-Burriel I, Bolea R, Sanz A, Varona L, Godino J, Gallego B, Garcia-Erce JA, Villar I, Gil V, Forner M, Cubero JP, Ros L. Epigenetics modifications and Subclinical Atherosclerosis in Obstructive Sleep Apnea: The EPIOSA study. BMC Pulm Med. 2014 Jul 12;14:114. doi: 10.1186/1471-2466-14-114.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
Same as current
March 2019
March 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 18 to 60

Exclusion Criteria:

  • Any comorbid condition
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact: Jose M Marin, M.D. +34976765500 jmmarint@unizar.es
Spain
 
 
NCT02131610
PI12/02175 ( Other Identifier: FISS )
No
Not Provided
Not Provided
Aragon Institute of Health Sciences
Aragon Institute of Health Sciences
  • Instituto Aragones de Ciencias de la Salud
  • Hospital Miguel Servet
Principal Investigator: Jose M Marin, M.D. Hospital Universitario Miguel Servet
Aragon Institute of Health Sciences
April 2014