Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome

February 16, 2015 updated by: Universidade Nova de Lisboa

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisbon, Portugal
        • Centro Hospitalar Lisboa Norte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Obstructive Sleep Apnoea Syndrome Males 25-60 years

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CPAP
Patients with moderate/severe OSAS will be treated with CPAP
Control
Patients with snoring will not be subject to treatment with CPAP

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Nova de Lisboa

Collaborators

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

Investigators

  • Principal Investigator: Amélia Feliciano, MD, Centro Hospitalar Lisboa Norte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

January 21, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Estimate)

February 18, 2015

Last Update Submitted That Met QC Criteria

February 16, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCM-

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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