NCT02131610

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

May 6, 2014

Status Verified

April 1, 2014

Enrollment Period

5 years

First QC Date

April 16, 2014

Last Update Submit

May 4, 2014

Conditions

Sleep ApneaSnoring

Keywords

Sleep apneaObstructive sleep apneaSubclinical atherosclerosisEpigeneticsT cells

Outcome Measures

Primary Outcomes (1)

  • Incidence of cardiovascular events according with or without the presence of epigenetics changes in pro-inflammatory genes

    5 years

Secondary Outcomes (1)

  • biomarkers in blood and urine that correlates with OSA severity which may serve also as markers of disease progression.

    5 years

Study Arms (2)

Obstructive slep apnea patients

Patients with OSA

Control group

Subjects without OSA

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects that will be study because suspected OSA

You may qualify if:

  • Age between 18 to 60

You may not qualify if:

  • Any comorbid condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 25016368DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma samples.

MeSH Terms

Conditions

Sleep Apnea SyndromesSnoringSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jose M Marin, M.D.

    Hospital Miguel Servet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose M Marin, M.D.

CONTACT

+34976765500jmmarint@unizar.es

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2014

First Posted

May 6, 2014

Study Start

March 1, 2013

Primary Completion

March 1, 2018

Study Completion

March 1, 2019

Last Updated

May 6, 2014

Record last verified: 2014-04

Locations

ES(1)