Epigenetics Modifications in Obstructive Sleep Apnea | NCT02131610

Studies
Epigenetics Modifications in Obstructive Sleep Apnea

NCT02131610

Sponsor

Aragon Institute of Health Sciences

Status

Unknown status

Last Update Posted

May 6, 2014Estimated

Enrollment

350Estimated

Phase

Not provided

Conditions

Sleep Apnea
Snoring

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PI12/02175	Other Identifier	FISS

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Mar 2018Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

Apr 16, 2014

First Submission Date that Met QC Criteria

May 4, 2014

First Posted Date

May 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2014

Last Update Posted Date

May 6, 2014Estimated

Name	Class
Instituto Aragones de Ciencias de la Salud	OTHER_GOV
Hospital Miguel Servet	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

350Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Obstructive slep apnea patients		Patients with OSA
Control group		Subjects without OSA

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 to 60

Exclusion Criteria:

Any comorbid condition

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Subjects that will be study because suspected OSA

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jose M Marin, M.D.	Contact	+34976765500		jmmarint@unizar.es

Overall Officials

Name	Affiliation	Role
Jose M Marin, M.D.	Hospital Miguel Servet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Miguel Servet	Recruiting	Zaragoza		50009	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25016368	Derived	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.

ID	Term
D012891	Sleep Apnea Syndromes
D012913	Snoring
D020181	Sleep Apnea, Obstructive

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic