Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Centro de Estudos de Doenças Crónicas
NOVA Medical School
Centro Hospitalar Lisboa Norte
Instituto Nacional de Saúde Dr. Ricardo Jorge
Biotempo
Fundação para a Ciência e a Tecnologia
Information provided by (Responsible Party):
Universidade Nova de Lisboa
ClinicalTrials.gov Identifier:
NCT02043483
First received: November 12, 2013
Last updated: January 21, 2014
Last verified: January 2014

November 12, 2013
January 21, 2014
October 2012
January 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02043483 on ClinicalTrials.gov Archive Site
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.
Same as current
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Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome
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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Obstructive Sleep Apnoea Syndrome Males 25-60 years

Obstructive Sleep Apnoea Syndrome
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  • CPAP
    Patients with moderate/severe OSAS will be treated with CPAP
  • Control
    Patients with snoring will not be subject to treatment with CPAP
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Male
25 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT02043483
FCM-
No
Universidade Nova de Lisboa
Universidade Nova de Lisboa
  • Centro de Estudos de Doenças Crónicas
  • NOVA Medical School
  • Centro Hospitalar Lisboa Norte
  • Instituto Nacional de Saúde Dr. Ricardo Jorge
  • Biotempo
  • Fundação para a Ciência e a Tecnologia
Principal Investigator: Amélia Feliciano, MD Centro Hospitalar Lisboa Norte
Universidade Nova de Lisboa
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP