跳至主要内容
临床试验/NCT06452979
NCT06452979招募中不适用

Mucosal Inflammation in Children With OSA - Potential Biomarkers of OSA Complications

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
110
试验地点
1
主要终点
Inflammatory profile in the nasal fluid

研究概览

简要总结

Objectives: Variability of clinical phenotypes in childhood obstructive sleep apnoea (OSA) has prompted research for biomarkers to identify patients at risk of developing OSA-related complications. Upper airway inflammation is documented in children with OSA. Whether it is related to end-organ morbidities and systemic inflammation is under-explored. The primary objectives of our study are 1)To evaluate inflammatory biomarkers with the use of nasal epithelial lining fluid (NELF) collected by nasal strips as a representation of upper airway inflammation in children with OSA compared to non-OSA controls; 2) To evaluate the associations between NELF biomarkers with ambulatory blood pressure (ABP) outcomes in children with OSA.

Hypothesis to be tested: Inflammatory biomarkers in NELF in children with OSA are altered when compared with non-OSA controls and correlated with ABP outcomes.

Design and subjects: A prospective case-control study. Non-obese Chinese children aged 6-11 years old with habitual snoring (≥3 nights per week) and polysomnography (PSG) confirmed OSA (OAHI of ≥1/hour) will be recruited as cases. Non-OSA children with OAHI < 1 event/h will be recruited as controls. All subjects will undergo evaluation including questionnaires, anthropometric measurements, PSG, 24-hour ABP measurement, blood and NELF sampling.

Primary outcome measure: Profile of inflammatory biomarkers in the NELF. Analysis: Correlations between NELF inflammatory biomarkers with polysomnographic and ABP measurements will be evaluated by regression analysis.

Expected results: This study will provide novel and important information regarding upper airway inflammatory biomarkers in children with OSA and their relationship with blood pressure outcomes.

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
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 6-11 years old

排除标准

  • Previous upper airway surgery, genetic or syndromal disease, congenital or acquired neuromuscular disease, suspected or confirmed congenital or acquired immunodeficiency, obesity (BMI z-score ≥1.645), known metabolic syndrome, craniofacial abnormalities, structural or congenital heart disease, use of medications or therapy that could affect immunity such as systemic corticosteroids, chemotherapy, radiation therapy, intravenous immunoglobulins.

结局指标

主要结局

Inflammatory profile in the nasal fluid

时间窗: 3 years

Profile of inflammatory biomarkers in the nasal epithelial lining fluid: cytokines profiles

次要结局

  • Inflammatory profile in the peripheral blood(3 years)

研究者

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

Kate Ching Ching Chan

Associate Professor

Chinese University of Hong Kong

研究点 (1)

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