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
  Purpose

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
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
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
CPAP
Patients with moderate/severe OSAS will be treated with CPAP
Control
Patients with snoring will not be subject to treatment with CPAP

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Universidade Nova de Lisboa
ClinicalTrials.gov Identifier: NCT02043483     History of Changes
Other Study ID Numbers: FCM-
Study First Received: November 12, 2013
Last Updated: January 21, 2014
Health Authority: Portugal: Ministry of Health

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:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014