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Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome

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ClinicalTrials.gov Identifier: NCT02043483
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : February 18, 2015
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

Brief 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.


Condition or disease
Obstructive Sleep Apnoea Syndrome

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Obstructive Sleep Apnoea and Associated Metabolic/Cardiovascular Disorders: Understanding Mechanisms Towards Early Diagnosis and Prognosis
Study Start Date : October 2012
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043483


Locations
Portugal
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
Biotempo
Fundação para a Ciência e a Tecnologia
Investigators
Principal Investigator: Amélia Feliciano, MD Centro Hospitalar Lisboa Norte

Responsible Party: Universidade Nova de Lisboa
ClinicalTrials.gov Identifier: NCT02043483     History of Changes
Other Study ID Numbers: FCM-
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015

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

Additional relevant MeSH terms:
Syndrome
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases