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Completed

NCT Number: NCT01365832

Change in C-reactive Protein (CRP) in Men and Women With Sleep Apnea After Continuous Positive Airway Pressure (CPAP)

C-reactive protein (CRP) is directly implicated in atherogenesis and associated cardiovascular morbidity in patients with obstructive sleep apnea (OSA). Effective Continuous Positive Airway Pressure (CPAP) treatment has been shown to gradually decrease CRP levels and thus consequently improve disease-related cardiovascular morbidity. However, the influence of gender on the CRP evolution pattern has never been assessed before. The aim of our study was to investigate possible gender differences in CRP evolution in OSA patients 3 and 6 months after the start of effective CPAP treatment.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete

Heraklion, Crete, 71110, Greece

About this study

OSA is an independent risk factor for a number of cardiovascular diseases. One important possible mechanism underlying cardiovascular disease in patients with OSA is systemic inflammation. CRP, an acute phase reactant secreted by the liver, is one of the most actively studied biomarkers of low-grade inflammation, and numerous studies have shown that higher CRP levels are associated with high mortality and morbidity due to cardiovascular disease in men and women. In patients with OSA, the question as to whether or not CRP levels are elevated is still under debate. Although continuous positive airway pressure (CPAP) is effective in the management of OSA, conflicting data also exist regarding the effects of CPAP on CRP levels. However, none of the existing studies assessed the influence of gender on the CRP evolution pattern. Therefore, the aim of this study was to investigate possible gender differences in CRP evolution in patients with moderate to severe OSA, free of medical comorbidities, 3 and 6 months after the start of effective CPAP treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with apnoea-hypopnoea index >15/h

Exclusion criteria

  • chronic obstructive pulmonary disease
  • diabetes mellitus
  • coronary artery disease
  • congestive heart failure
  • chronic renal failure
  • known dyslipidemia
  • smoking history
  • hypothyroidism
  • chronic or recent infectious or inflammatory disease
  • use of anti-inflammatory or antibiotic drugs, or statins.
  • postmenopausal females on estrogen replacement therapy.

Treatment and study plan

Continuous Positive Airway Pressure (CPAP)

Procedure

Continuous positive airway pressure (CPAP) is the gold standard for Obstructive Sleep Apnea (OSA) management. Subjects with OSA will be trained in the use of CPAP and will be instructed to use CPAP every night for 6 months. These subjects will then return for a post-treatment blood draw 3 and 6 months after the start of effective CPAP treatment

Other names: positive pressure ventilation

Primary outcomes

  1. Change in CRP in OSA patients, according to gender, 3 and 6 months after the start of effective CPAP treatment.

    Time frame: Day 1, Month 3 and Month 6 post treatment

Sponsors and collaborators

Lead sponsor

University of Crete

Other

Registry information

Official study title

CRP Evolution Pattern in CPAP Treated Obstructive Sleep Apnea Patients. Does Gender Play a Role?

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 3, 2011
Registry last updated
Jun 6, 2011

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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