Epigenetics Modifications in Obstructive Sleep Apnea

Sleep Apnea Clinical Trial

— EPIOSA  

Official title:

Epigenetics Modifications and Subclinical Atherosclerosis in Obstructive Sleep Apnea: The EPIOSA Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02131610
• Other study ID #: NCT01475421
• Secondary ID: PI12/02175
• Status: Recruiting
• Phase: N/A
• First received: April 16, 2014
• Last updated: May 4, 2014
• Start date: March 2013
• Est. completion date: March 2019

Study information

• Verified date: April 2014
• Source: Aragon Institute of Health Sciences
• Contact: Jose M Marin, M.D.
• Phone: +34976765500
• Email: jmmarint[@]unizar.es
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: March 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age between 18 to 60

Exclusion Criteria:

• Any comorbid condition

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Snoring

Locations

Country	Name	City	State
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
Aragon Institute of Health Sciences	Hospital Miguel Servet, Instituto Aragones de Ciencias de la Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cardiovascular events according with or without the presence of epigenetics changes in pro-inflammatory genes		5 years	No
Secondary	biomarkers in blood and urine that correlates with OSA severity which may serve also as markers of disease progression.		5 years	No