Epigenetics Modifications in Obstructive Sleep Apnea

NCT ID: NCT02131610

Last Updated: 2014-05-06

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2019-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Sleep Apnea Snoring

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

* Age between 18 to 60

Exclusion Criteria

* Any comorbid condition
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Aragones de Ciencias de la Salud

OTHER_GOV

Sponsor Role collaborator

Hospital Miguel Servet

OTHER

Sponsor Role collaborator

Aragon Institute of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Jose M Marin, M.D.

Role: CONTACT

+34976765500

Facility Contacts

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Jose M Marin, M.D.

Role: primary

+34 976765500 ext. 1941

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.

Reference Type DERIVED
PMID: 25016368 (View on PubMed)

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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