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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Procedure: Continuous Positive Airway Pressure (CPAP)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 436
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Crete
    • Heraklion, Crete, Greece, 71110
      • Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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)

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 Names: positive pressure ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Crete

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: May 17, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Estimate): June 6, 2011
• Last Update Submitted That Met QC Criteria: June 3, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: OSACRP-02