To Assess the Differences in Chemokines and Oxidative Stress Markers in Exhaled Breath Condensate of Obstructive Sleep Apnoea Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in the biomarkers in breath over a period of time in subjects with CPAP and no CPAP treatment for the OSA
研究概览
简要总结
Patients with obstructive sleep apnoea (OSA) have repetitive episodes of partial or complete upper airway obstruction during sleep. This leads to sleep fragmentation and symptoms like excessive daytime sleepiness and impaired psychosocial well-being. More evidence now suggested OSA is associated with cardiovascular diseases like hypertension, myocardial infarction, pulmonary hypertension and stroke.
The upper airway structure and function are altered in OSA. Some studies suggested that an increase in the levels of systemic biomarkers of inflammation and oxidative stress in patients with OSA. So far, there is only very limited data on non-invasive monitoring of inflammation involved in the upper airway of OSA patients. The inflammatory mechanisms involved in the upper airway may give some insights to the systemic effect, like cardiovascular complications, of OSA.
Measurement of the constituents of exhaled breath and exhaled breath condensate (EBC) is a non-invasive method to assess the degree of inflammation of the airway. Exhaled nitric oxide (eNO) can be measured with the subject exhaling to a mouthpiece connected to a machine measuring real-time eNO level. With the subject exhaling to a cooling unit, EBC can be collected as liquid is formed as a result of condensation.
This study will assess the eNO in exhaled breath, oxidative stress marker (8-isoprostane) and cellular inflammatory markers (eotaxin, monocyted derived chemokine, growth related oncogene- alpha, monocyte chemoattractant protein-1) in the EBC and blood of OSA patients before and after 1 night and 3 months of continuous positive airway pressure treatment.
详细描述
Measurement of exhaled Nitric Oxide and collection of exhaled breath condensate and peripheral blood. This will be done 2 to 4 times(on admission,the morning after sleep study,immediately after CPAP titration, after CPAP use for 3 months). Each time eNO will be measured first, followed by EBC collection.
For the tests in the morning, patients will be asked to postpone his/her breakfast until after the test which will take less than half an hour.
OSA is defined as patients having a respiratory disturbance index of ≥5/hr.
Measurement of Exhaled Nitric Oxide:
eNO will be measured using a Sievers 280i chemiluminescence analyser (Sievers Instruments, Boulder, CO, USA) sensitive to NO from 1 ppb to 200 ppm and with a resolution of 1 ppb and accuracy of 1 ppb designed for online recording. The eNO measurement will be performed according to ATS standards. Briefly, subjects should remain seated without nose clip during the procedure, with 2-minute rest between eNO measurements. The eNO will be measured online at an expiratory flow rate of 50 ml/sec, a dead space of 10 ml and 2-second plateau duration. Repeated exhalations are performed until three NO plateau values agree at the 10% level or two agree at the 5% level. The mean NO value will then be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be recruited upon admission for sleep study under the Division of Respiratory Medicine, Prince of Wales Hospital.
- •Patients who are aged 18 to 60 will be recruited.
排除标准
- •Known history of respiratory disease that will affect inflammatory markers in EBC like asthma, chronic obstructive pulmonary disease and bronchiectasis.
- •Upper or lower respiratory tract infection within 6 weeks from the study.
- •Current smokers, or ex-smoker who quitted for less than a year.
- •Pregnant subjects.
- •Any form of malignancies or serious medical illness that will affect the survival of the subject significantly in 1 year period.
结局指标
主要结局
Changes in the biomarkers in breath over a period of time in subjects with CPAP and no CPAP treatment for the OSA
时间窗: 3 months
次要结局
未报告次要终点