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EPIOSA: Epigenetics Modifications in Obstructive Sleep Apnea

Sponsor
Aragon Institute of Health Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT02131610
Collaborator
Instituto Aragones de Ciencias de la Salud (Other), Hospital Miguel Servet (Other)
350
Enrollment
1
Location
72
Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    350 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Epigenetics Modifications and Subclinical Atherosclerosis in Obstructive Sleep Apnea: The EPIOSA Study
    Study Start Date :
    Mar 1, 2013
    Anticipated Primary Completion Date :
    Mar 1, 2018
    Anticipated Study Completion Date :
    Mar 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Obstructive slep apnea patients

    Patients with OSA
    Control group

    Subjects without OSA

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of cardiovascular events according with or without the presence of epigenetics changes in pro-inflammatory genes [5 years]

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age between 18 to 60
    Exclusion Criteria:
    • Any comorbid condition

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Miguel Servet Zaragoza Spain 50009

    Sponsors and Collaborators

    • Aragon Institute of Health Sciences
    • Instituto Aragones de Ciencias de la Salud
    • Hospital Miguel Servet

    Investigators

    • Principal Investigator: Jose M Marin, M.D., Hospital Miguel Servet

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aragon Institute of Health Sciences
    ClinicalTrials.gov Identifier:
    NCT02131610
    Other Study ID Numbers:
    • NCT01475421
    • PI12/02175
    First Posted:
    May 6, 2014
    Last Update Posted:
    May 6, 2014
    Last Verified:
    Apr 1, 2014
    Keywords provided by Aragon Institute of Health Sciences
    Sleep apnea
    Obstructive sleep apnea
    Subclinical atherosclerosis
    Epigenetics
    T cells
    Additional relevant MeSH terms:
    Apnea
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive
    Snoring

    Study Results

    No Results Posted as of May 6, 2014