Molecular Profile of Cardiovascular Risk in Obstructive Sleep Apnea Patients: Personalized Predictive Model.

NCT03513926 | Completed DMC

• 1 other identifier: PI14/01266
• Study Type: observational
• Target: 338
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of anthropometric, clinical and biological profile in four groups that represents transversely the natural history of Obstructive Sleep Apnea (OSA) and its associated cardiovascular comorbidities: non-OSA, OSA without hypertension, OSA and with hypertension and OSA with a cardiovascular event (CVE).

Conditions

Obstructive Sleep Apnea; Hypertension; Cardiovascular Diseases

Keywords

miRNA; Cardiovascular Risk; CPAP; Obstructive Sleep Apnea; Hypertension; Molecular profile

Outcome Measures

Primary Outcomes (1)

• Modeling the cardiovascular (CV) disease risk in patients with obstructive sleep apnea (OSA) through the analysis of the number and specific biomarkers.

  Anthropometric, clinical, analytical and biological variables characterization from different populations:non-OSA, OSA without hypertension, OSA with hypertension and OSA with a CV event. The evaluation of these variables will permit the characterization of the profile associated with CV disease in patients with OSA.

  Baseline

Secondary Outcomes (2)

• Modeling the effect of the treatment with continuous positive airway pressure (CPAP) in patients with OSA with and without cardiovascular disease, through the analysis of the number and specific biomarkers.

  After 6 months of follow-up

• Predictive model of cardiovascular risk

  After 6 months of follow-up

Study Arms (4)

Non-OSA group

Patients with out sleep apnea.

OSA group

Patients with OSA, without cardiovascular comorbidities who could be treated with Continuous Positive Airway Pressure

Device: Continuous Positive Airway Pressure

OSA with hypertension group

Patients with OSA, with hypertension who could be treated with Continuous Positive Airway Pressure

Device: Continuous Positive Airway Pressure

OSA with CVE group

Patients with OSA, with a previous ictus or stroke who could be treated with Continuous Positive Airway Pressure

Device: Continuous Positive Airway Pressure

Interventions

Continuous Positive Airway Pressure DEVICE

Continuous Positive Airway Pressure

Also known as: CPAP

OSA group; OSA with CVE group; OSA with hypertension group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Suspected OSA patients attending consecutively to the Sleep Unit of the University Hospital Arnau de Vilanova- Santa María de Lleida are included.

You may qualify if:

• Consecutive patients with suspected OSA that attend to Sleep Unit of Hospital Arnau de Vilanova- Santa Maria de Lleida.
• years old

You may not qualify if:

• Any chronic disease (malignancy, renal insufficiency (glomerular filtration rate \<30 ml / min), severe chronic obstructive pulmonary disease, chronic depression and other chronic diseases very limiting),
• Any sleep disorder previously diagnosed: narcolepsy, insomnia, chronic lack of sleep, regular use of hypnotic or sedative drugs and restless leg syndrome
• Any genetic abnormality or disease
• Any medical, social or geographical factors which may endanger patient compliance. (For example, consumption of alcohol (more than 80 g / day in men and 60 g / day in women), disorientation, or a history of default).

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead
• Fondo de Investigacion Sanitaria: collaborator

Study Sites (1)

Hospital Universitario Santa Maria de Lleida

Lleida, 25198, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma and buffy coat

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypertension; Cardiovascular Diseases

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ferran Barbé, MD

  Sociedad Española de Neumología y Cirugía Torácica

  PRINCIPAL INVESTIGATOR

• Manuel Sanchez-de-la-Torre, PhD

  Consorcio Centro de Investigación Biomédica en Red (CIBER)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 2, 2018
• Study Start: November 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: September 1, 2018
• Last Updated: April 8, 2019

Record last verified: 2019-04

Locations

ES (1)