Using a Portable Monitoring Device for Diagnosing Obstructive Sleep Apnea in Patients With Multiple Co-existing Medical Illnesses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess the accuracy of the new portable sleep study device with reference to concurrent PSG.
研究概览
简要总结
The standard sleep study for diagnosing obstructive sleep apnea (OSA) in patients with co-existing illness is by conducting an attended polysomnography (PSG) with more than 7 channels for recording physiological parameters in the sleep center, as recommended by international guidelines. However the guidelines are more than 10 year old without update. With the growing and aging of the population, there is a need to explore if portable monitoring devices could be used in this group of population, so this group of patients can be managed in a timely manner. Portable monitoring devices have been used widely in patients without significant co-existing illness. These devices record at least 4 physiological parameters for diagnosing OSA and can be performed in an unattended setting e.g. at home because of the simplicity. This can shorten the waiting time for making a diagnosis using PSG.
Eighty patients suspected of OSA, with stable co-existing illnesses, will be recruited for the study. Informed consent will be signed before participation. They will be offered a standard attended PSG in the sleep center. A portable monitoring device "Nox T3" will be hooked up to the patients concurrently during the PSG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- 否
入选标准
- •Adult patients suspect of OSA (with or without symptoms) of age between 18 to 80 years old, with or without significant comorbidities.
- •Patients consent of concurrent use of both type I and or type III devices at the same time in hospital setting.
排除标准
- •Pregnant patients.
- •Patients refuse to have both type I and type III devices used concurrently.
- •Patients with any co-existing medical illnesses which are unstable. "Unstable" is defined as:
- •Any recent hospital admission within 1 month before the schedule of sleep study
- •Any recent change of medication within 1 month before the schedule of sleep study
- •Any change in patient conditions requiring medical attention within 1 month before the schedule of sleep study.
结局指标
主要结局
To assess the accuracy of the new portable sleep study device with reference to concurrent PSG.
时间窗: 1 year
compare the AHI of NOX T3 with reference to PSG
次要结局
未报告次要终点
研究者
To Kin Wang
Associate consultant
Chinese University of Hong Kong
