Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome

Obstructive Sleep Apnoea and Associated Metabolic/Cardiovascular Disorders: Understanding Mechanisms Towards Early Diagnosis and Prognosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02043483

Enrollment

120

Registered

2014-01-23

Start date

2012-10-31

Completion date

2014-12-31

Last updated

2015-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnoea Syndrome

Keywords

CPAP, OSAS, CEDOC (Centro de Estudos de Doenças Crónicas), FCM (Faculdade de Ciências Médicas), UNL (Universidade Nova de Lisboa, NOVA MEDICAL SCHOOL, FCT (Fundação para a Ciência e Tecnologia)

Brief summary

Untreated Obstructive Sleep Apnea Syndrome (OSAS) has long-term complications, namely metabolic imbalances (obesity, dislipidemia, type 2 diabetes mellitus). Until now, no molecular markers for this physiopathological connection have been identified. This project aims to determine non-invasive biomarkers that may allow better comprehension of the metabolic consequences of OSAS, as well as assess the effect of Continuous positive airway pressure (CPAP) on these metabolic parameters. This project will integrate the clinical, metabolic, genetic/proteomic and biologic systems to further explore the mechanisms behind OSAS, as well as the effect of the treatment with CPAP.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

25 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Male * 25-60 years * Mild/Moderate/Severe OSAS

Exclusion criteria

* Female * Other sleep disorders * Previous CPAP therapy * Type 1 diabetes mellitus * Familiar Dyslipidemia * Severe organ pathology * Acute disease

Design outcomes

Primary

Measure	Time frame	Description
Percentage of patients with clinical improvement	6 months	Treatment efficacy of CPAP will be assessed at the end of treatment through a clinical observation.

Secondary

Measure	Time frame	Description
Frequency of occurence of biomarkers	6 months	Using Mass Spectrometric Immunoassay, we will identify which biomarkers have a positive association with long-term treatment effect.

Countries

Portugal

Outcome results