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临床试验/NCT07129486
NCT07129486尚未招募不适用

Intermittent-Hypoxia Inhibits Neutrophil Extracellular Traps Formation: Role of Cathelicidins

Kun-Ta Chou1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
NET activity of neutrophils induced by PMA

研究概览

简要总结

The study will enroll 80 moderate-to-severe Obstructive sleep apnea (OSA) patients (40 obese) and 40 age-, gender-, and body mass index-matched controls. Venous blood will be collected to isolate neutrophils, which will be tested for the ability to produce neutrophil extracellular traps (NETs) along with the levels of LL-37 and NETs products in the blood. Measurements will be repeat after three months treatment for OSA.

详细描述

Obstructive sleep apnea (OSA) is characterized by repetitive upper airway collapse during sleep, thereby leading to intermittent hypoxia (IH). Literature revealed OSA confers a higher risk for poor infection outcomes, suggestive of defective immunity in those patients. This research aimed to investigate whether IH inhibits neutrophils to produce neutrophil extracellular traps (NETs) via Cathelicidins (LL-37). The human study will enroll 80 moderate-to-severe OSA patients (40 obese) and 40 age-, gender-, and body mass index-matched controls. Venous blood will be collected to isolate neutrophils, which receive either IH treatment (1% O2 for 35 mins and 21% for 25 mins per cycle, 3 cycles) or normoxic treatment. The neutrophils will be tested for the ability to produce NETs along with the levels of LL-37 and NETs products in the blood. Measurements will be repeat three months after the mainstay continuous positive airway pressure (CPAP) therapy.

研究设计

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

入排标准

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

入选标准

  • At least 20 years old, with moderate to severe OSA (AHI ≥ 15/hour), and willing to participate in the study.

排除标准

  • Under 20 years old, suffering from diseases or conditions that may affect immune function (e.g., tumors, chemotherapy, autoimmune diseases, diabetes, chronic kidney disease, etc.), or unwilling to participate in the study

结局指标

主要结局

NET activity of neutrophils induced by PMA

时间窗: From enrollment to receiving CPAP therapy for 3 months

10 cc peripheral venous blood of participants will be collected at enrollment and 3 months after CPAP therapy (if received it). Neutrophils are isolated from peripheral blood and stimulated with PMA (phorbol 12-myristate 13-acetate) to induce the formation of NETs. The effects were tested with or without intermittent hypoxia (IH) treatment (1% O₂ for 35 minutes followed by 21% O₂ for 25 minutes per cycle, repeated for three cycles). The extent of NETs formation was assessed by confocal microscopy and images were exported as multi-channel TIFF files and analyzed using custom Python scripts (NumPy, scikit-image).

DNA-MPO (Myeloperoxidase) complex in plasma

时间窗: From enrollment to receiving CPAP therapy for 3 months

Description: 10 cc peripheral venous blood of participants will be collected at enrollment and 3 months after CPAP therapy (if received it). Plasma is collected and tested for DNA-MPO (Myeloperoxidase) complex by ELISA (Enzyme-linked immunosorbent assay).

LL-37 level in plasma

时间窗: From enrollment to receiving CPAP therapy for 3 months

10 cc peripheral venous blood of participants will be collected at enrollment and 3 months after CPAP therapy (if received it). Plasma is collected and tested for LL-37 by ELISA (Enzyme-linked immunosorbent assay).

次要结局

未报告次要终点

研究者

发起方
Kun-Ta Chou
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Kun-Ta Chou

Chief

Taipei Veterans General Hospital, Taiwan

研究点 (1)

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