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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365832
• Other study ID #: OSACRP-02
• Status: Completed
• Phase: N/A
• First received: May 17, 2011
• Last updated: June 3, 2011
• Start date: January 2007
• Est. completion date: June 2009

Study information

• Verified date: April 2011
• Source: University of Crete
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Greece	Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete	Heraklion	Crete

Sponsors (1)

Lead Sponsor	Collaborator
University of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CRP in OSA patients, according to gender, 3 and 6 months after the start of effective CPAP treatment.		Day 1, Month 3 and Month 6 post treatment	No