Epigenetics Modifications in Obstructive Sleep Apnea (EPIOSA)

May 4, 2014 updated by: Aragon Institute of Health Sciences

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Miguel Servet
        • Contact:
        • Sub-Investigator:
          • Maria T Martin, M.D.
        • Principal Investigator:
          • Jose M Marin, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects that will be study because suspected OSA

Description

Inclusion Criteria:

  • Age between 18 to 60

Exclusion Criteria:

  • Any comorbid condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Obstructive slep apnea patients
Patients with OSA
Control group
Subjects without OSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of cardiovascular events according with or without the presence of epigenetics changes in pro-inflammatory genes
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
biomarkers in blood and urine that correlates with OSA severity which may serve also as markers of disease progression.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aragon Institute of Health Sciences

Collaborators

Instituto Aragones de Ciencias de la Salud
Hospital Miguel Servet

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

May 4, 2014

First Posted (Estimate)

May 6, 2014

Study Record Updates

Last Update Posted (Estimate)

May 6, 2014

Last Update Submitted That Met QC Criteria

May 4, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT01475421
  • PI12/02175 (Other Identifier: FISS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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