Clinical trial NCT01365832: Change in C-reactive Protein (CRP) in Men and Women With Sleep Apnea After Continuous Positive Airway Pressure (CPAP)
Official title: CRP Evolution Pattern in CPAP Treated Obstructive Sleep Apnea Patients. Does Gender Play a Role?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: University of Crete
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 436
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in CRP in OSA patients, according to gender, 3 and 6 months after the start of effective CPAP treatment.
timeFrame: Day 1, Month 3 and Month 6 post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: Sleep Disorders Unit, Department of Thoracic Medicine, Medical School, University of Crete
state: Crete
Study officials:
affiliation: University of Crete
name: Sophia E Schiza, MD, PhD
role: STUDY_CHAIR
affiliation: Sleep Disorders Center, Pulmonary Department, 401 General Army Hospital, Athens, Greece
name: Charalampos Mermigkis, MD
role: STUDY_DIRECTOR
affiliation: University of Crete
name: Izolde Bouloukaki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: