Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome

Obstructive Sleep Apnoea Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043483
• Other study ID #: FCM-
• Status: Completed
• Phase: N/A
• First received: November 12, 2013
• Last updated: February 16, 2015
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Universidade Nova de Lisboa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnoea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Lisboa Norte	Lisbon

Sponsors (7)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa	Biotempo, Centro de Estudos de Doenças Crónicas, Centro Hospitalar Lisboa Norte, Fundação para a Ciência e a Tecnologia, Instituto Nacional de Saúde Dr. Ricardo Jorge, NOVA Medical School

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with clinical improvement	Treatment efficacy of CPAP will be assessed at the end of treatment through a clinical observation.	6 months	No
Secondary	Frequency of occurence of biomarkers	Using Mass Spectrometric Immunoassay, we will identify which biomarkers have a positive association with long-term treatment effect.	6 months	No