Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
350 participants
OBSERVATIONAL
2013-03-31
2019-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Obstructive slep apnea patients
Patients with OSA
No interventions assigned to this group
Control group
Subjects without OSA
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
Yes
Sponsors
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Instituto Aragones de Ciencias de la Salud
OTHER_GOV
Hospital Miguel Servet
OTHER
Aragon Institute of Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Jose M Marin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital Miguel Servet
Locations
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Hospital Miguel Servet
Zaragoza, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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PI12/02175
Identifier Type: OTHER
Identifier Source: secondary_id
NCT01475421
Identifier Type: -
Identifier Source: org_study_id
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