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Epigenetics Modifications in Obstructive Sleep Apnea (EPIOSA)

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ClinicalTrials.gov Identifier: NCT02131610
Recruitment Status : Recruiting
First Posted : May 6, 2014
Last Update Posted : May 6, 2014
Sponsor:
Collaborators:
Instituto Aragones de Ciencias de la Salud
Hospital Miguel Servet
Information provided by (Responsible Party):
Aragon Institute of Health Sciences

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

Condition or disease
Sleep Apnea Snoring

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 [Patient Registry]
Estimated Enrollment : 350 participants
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
Study Start Date : March 2013
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Incidence of cardiovascular events according with or without the presence of epigenetics changes in pro-inflammatory genes [ Time Frame: 5 years ]

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

Biospecimen Retention:   Samples Without DNA
serum and plasma samples.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aragon Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT02131610     History of Changes
Other Study ID Numbers: PI12/02175 ( Other Identifier: FISS )
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: April 2014

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

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