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

NCT ID: NCT01365832

Last Updated: 2011-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 436 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-06-30

Brief 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.

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Continuous Positive Airway Pressure (CPAP)

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

positive pressure ventilation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Crete

OTHER

Sponsor Role: lead

Responsible Party

University of Crete

Principal Investigators

Sophia E Schiza, MD, PhD

Role: STUDY_CHAIR

University of Crete

Charalampos Mermigkis, MD

Role: STUDY_DIRECTOR

Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece

Izolde Bouloukaki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Crete

Locations

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

Heraklion, Crete, Greece

Countries

Greece

Other Identifiers

OSACRP-02

Identifier Type: -

Identifier Source: org_study_id