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

This study has been completed.
Sponsor:
Information provided by:
University of Crete
ClinicalTrials.gov Identifier:
NCT01365832
First received: May 17, 2011
Last updated: June 3, 2011
Last verified: April 2011

May 17, 2011
June 3, 2011
January 2007
June 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01365832 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Change in C-reactive Protein (CRP) in Men and Women With Sleep Apnea After Continuous Positive Airway Pressure (CPAP)
CRP Evolution Pattern in CPAP Treated Obstructive Sleep Apnea Patients. Does Gender Play a Role?

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obstructive Sleep Apnea
Procedure: Continuous Positive Airway Pressure (CPAP)
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 Name: positive pressure ventilation
Experimental: Sleep apnea

Participants with Obstructive Sleep Apnea (OSA).This arm will undergo a pre-treatment blood draw, six months of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw 3 and 6 months later.

Intervention: Procedure: Continuous Positive Airway Pressure (CPAP)

Intervention: Procedure: Continuous Positive Airway Pressure (CPAP)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
436
June 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01365832
OSACRP-02
No
Sophia Schiza, University of Crete
University of Crete
Not Provided
Study Chair: Sophia E Schiza, MD, PhD University of Crete
Study Director: Charalampos Mermigkis, MD Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece
Principal Investigator: Izolde Bouloukaki, MD, PhD University of Crete
University of Crete
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP