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Completed

NCT Number: NCT02043483

Identification of Biomarkers for Obstructive Sleep Apnoea Syndrome

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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Key information

Conditions

Obstructive Sleep Apnoea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

25 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

Centro Hospitalar Lisboa Norte

Lisbon, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidade Nova de Lisboa

Other

Collaborators

  • Biotempo
  • Centro Hospitalar Lisboa Norte
  • Centro de Estudos de Doenças Crónicas
  • Fundação para a Ciência e a Tecnologia
  • NOVA Medical School
  • National Health Institute Dr. Ricardo Jorge

Registry information

Official study title

Obstructive Sleep Apnoea and Associated Metabolic/Cardiovascular Disorders: Understanding Mechanisms Towards Early Diagnosis and Prognosis

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 23, 2014
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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