Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome

This study has been completed.
Centro de Estudos de Doenças Crónicas
NOVA Medical School
Centro Hospitalar Lisboa Norte
Instituto Nacional de Saúde Dr. Ricardo Jorge
Fundação para a Ciência e a Tecnologia
Information provided by (Responsible Party):
Universidade Nova de Lisboa Identifier:
First received: November 12, 2013
Last updated: February 16, 2015
Last verified: February 2015

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.

Obstructive Sleep Apnoea Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Obstructive Sleep Apnoea and Associated Metabolic/Cardiovascular Disorders: Understanding Mechanisms Towards Early Diagnosis and Prognosis

Resource links provided by NLM:

Further study details as provided by Universidade Nova de Lisboa:

Primary Outcome Measures:
  • Percentage of patients with clinical improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Treatment efficacy of CPAP will be assessed at the end of treatment through a clinical observation.

Secondary Outcome Measures:
  • Frequency of occurence of biomarkers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Using Mass Spectrometric Immunoassay, we will identify which biomarkers have a positive association with long-term treatment effect.

Estimated Enrollment: 120
Study Start Date: October 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Patients with moderate/severe OSAS will be treated with CPAP
Patients with snoring will not be subject to treatment with CPAP


Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Obstructive Sleep Apnoea Syndrome Males 25-60 years

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02043483

Centro Hospitalar Lisboa Norte
Lisbon, Portugal
Sponsors and Collaborators
Universidade Nova de Lisboa
Centro de Estudos de Doenças Crónicas
NOVA Medical School
Centro Hospitalar Lisboa Norte
Instituto Nacional de Saúde Dr. Ricardo Jorge
Fundação para a Ciência e a Tecnologia
Principal Investigator: Amélia Feliciano, MD Centro Hospitalar Lisboa Norte
  More Information

No publications provided

Responsible Party: Universidade Nova de Lisboa Identifier: NCT02043483     History of Changes
Other Study ID Numbers: FCM-
Study First Received: November 12, 2013
Last Updated: February 16, 2015
Health Authority: Portugal: Ministry of Health

Keywords provided by Universidade Nova de Lisboa:
CEDOC (Centro de Estudos de Doenças Crónicas)
FCM (Faculdade de Ciências Médicas)
UNL (Universidade Nova de Lisboa
FCT (Fundação para a Ciência e Tecnologia)

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic processed this record on December 01, 2015