Epigenetics Modifications in Obstructive Sleep Apnea (EPIOSA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Aragon Institute of Health Sciences
Sponsor:
Collaborators:
Instituto Aragones de Ciencias de la Salud
Hospital Miguel Servet
Information provided by (Responsible Party):
Aragon Institute of Health Sciences
ClinicalTrials.gov Identifier:
NCT02131610
First received: April 16, 2014
Last updated: May 4, 2014
Last verified: April 2014
  Purpose

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


Condition
Sleep Apnea
Snoring

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Epigenetics Modifications and Subclinical Atherosclerosis in Obstructive Sleep Apnea: The EPIOSA Study

Resource links provided by NLM:


Further study details as provided by Aragon Institute of Health Sciences:

Primary Outcome Measures:
  • Incidence of cardiovascular events according with or without the presence of epigenetics changes in pro-inflammatory genes [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • biomarkers in blood and urine that correlates with OSA severity which may serve also as markers of disease progression. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum and plasma samples.


Estimated Enrollment: 350
Study Start Date: March 2013
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Obstructive slep apnea patients
Patients with OSA
Control group
Subjects without OSA

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects that will be study because suspected OSA

Criteria

Inclusion Criteria:

  • Age between 18 to 60

Exclusion Criteria:

  • Any comorbid condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02131610

Contacts
Contact: Jose M Marin, M.D. +34976765500 jmmarint@unizar.es

Locations
Spain
Hospital Miguel Servet Recruiting
Zaragoza, Spain, 50009
Contact: Jose M Marin, M.D.    +34 976765500 ext 1941    jmmarint@unizar.es   
Sub-Investigator: Maria T Martin, M.D.         
Principal Investigator: Jose M Marin, M.D.         
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 Universitario Miguel Servet
  More Information

No publications provided

Responsible Party: Aragon Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT02131610     History of Changes
Other Study ID Numbers: NCT01475421, PI12/02175
Study First Received: April 16, 2014
Last Updated: May 4, 2014
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Aragon Institute of Health Sciences:
Sleep apnea
Obstructive sleep apnea
Subclinical atherosclerosis
Epigenetics
T cells

Additional relevant MeSH terms:
Apnea
Atherosclerosis
Sleep Apnea Syndromes
Snoring
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Respiratory Sounds

ClinicalTrials.gov processed this record on August 20, 2014