Inflammatory Markers in Obstructive Sleep Apnea (OSA) Patients.

Study Overview
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Brief Summary
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The aim of our study was to assess the levels of inflammatory biomarkers in a large sample of OSA patients and to investigate any correlation between these markers with clinical and polysomnographic (PSG) parameters. Subjects undergone a PSG for OSA diagnosis were recruited. Patients with known comorbidities were excluded from the study. Included patients were grouped according to apnea-hypopnea index (AHI) as mild, moderate and severe. Patients with AHI < 5 served as control group. Demographic, PSG data, serum levels of hs-C-reactive protein (hs-CRP), fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) were measured and compared between groups.

Detailed Description
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Systemic inflammation is important in obstructive sleep apnea (OSA) pathophysiology and its comorbidity. The objective of this study was to investigate how early biomarkers of inflammation may be altered in OSA patients. To complete this goal the investigators assessed the circulating levels of four inflammatory markers, hs-C-reactive protein (hs-CRP), Fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) in a representative population of consecutively enrolled, untreated and otherwise healthy subjects with a clinical suspicion of obstructive sleep apnea. A secondary objective was to investigate any correlation between these markers with clinical and polysomnographic (PSG) parameters of these subjects.Subjects who had undergone a PSG for OSA diagnosis were recruited. Patients with known comorbidities were excluded from the study. Included patients were grouped according to apnea-hypopnea index (AHI) as mild, moderate and severe. Patients with AHI < 5 served as control group. Demographic, PSG data, serum levels of hs-CRP, fibrinogen, ESR and UA were measured and compared between groups.

Official Title
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Evaluation of Inflammatory Markers in a Large Sample of Obstructive Sleep Apnea Patients

Conditions
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Obstructive Sleep Apnea of Adult

Intervention / Treatment
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* Procedure: Venous blood collection for biomarkers measurements


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newly diagnosed, untreated, and otherwise healthy obstructive sleep apnea (OSA) patients healthy subjects (without OSA) Exclusion Criteria: refusal to participate, previous OSA diagnosis and treatment known comorbidities, pregnancy, history of narcolepsy or restless leg syndrome. Subjects younger than 18 years, Central sleep apnea syndrome (CSAS) diagnosed with PSG,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Subjects without Obstructive sleep apnea (Apnea-hypopnea index-AHI<5). Venous blood collection for biomarkers measurements. | Procedure: Venous blood collection for biomarkers measurements<br>* Venous blood was collected in all subjects for measurements of hs-C-reactive protein (hs-CRP), fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) between 8:00 and 9:00 AM, following an overnight fast, shortly after the conclusion of the overnight polysomnography (PSG).<br>|
| Obstructive sleep apnea (OSA) patients<br>Patients with Obstructive sleep apnea (AHI> or =5). Venous blood collection for biomarkers measurements. | Procedure: Venous blood collection for biomarkers measurements<br>* Venous blood was collected in all subjects for measurements of hs-C-reactive protein (hs-CRP), fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) between 8:00 and 9:00 AM, following an overnight fast, shortly after the conclusion of the overnight polysomnography (PSG).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory biomarkers levels in OSA patients without comorbidities compared to controls. | Inflammatory biomarkers levels in OSA patients without comorbidities compared to controls,as assessed by high sensitive -C-reactive protein (hs-CRP), Fibrinogen, Erythrocyte sedimentation rate (ESR) and uric acid (UA). | 4 years |