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Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02043483
First Posted: January 23, 2014
Last Update Posted: February 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
November 12, 2013
January 23, 2014
February 18, 2015
October 2012
December 2014   (Final data collection date for primary outcome measure)
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.
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 ]
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.

Not Provided
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
Not Provided
  • CPAP
    Patients with moderate/severe OSAS will be treated with CPAP
  • Control
    Patients with snoring will not be subject to treatment with CPAP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2014
December 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
Sexes Eligible for Study: Male
25 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Portugal
 
 
NCT02043483
FCM-
No
Not Provided
Not Provided
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
February 2015