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临床试验/NCT03070769
NCT03070769已完成不适用

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

University of Crete1 个研究点 分布在 1 个国家目标入组 1,053 人开始时间: 2012年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,053
试验地点
1
主要终点
Inflammatory biomarkers levels in OSA patients without comorbidities compared to controls.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • newly diagnosed, untreated, and otherwise healthy obstructive sleep apnea (OSA) patients
  • healthy subjects (without OSA)

排除标准

  • 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,

结局指标

主要结局

Inflammatory biomarkers levels in OSA patients without comorbidities compared to controls.

时间窗: 4 years

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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Izolde Bouloukaki

Principal Investigator

University of Crete

研究点 (1)

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