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临床试验/NCT03003702
NCT03003702已完成不适用

Domiciliary Monitoring to Predict Exacerbations of COPD

University College, London2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2016年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
85
试验地点
2
主要终点
The primary outcome is the difference in time to receive treatment from exacerbation onset as defined by symptoms, compared to exacerbation onset as defined by change in physiology

研究概览

简要总结

Chronic Obstructive Pulmonary Disease (COPD) is a common, long term condition of the lungs that is usually caused by cigarette smoking. In addition to daily symptoms and limitation in activities, patients are prone to developing chest infections called 'exacerbations'. Exacerbations are a big problem: unpleasant for patients, and sometimes severe enough to cause hospital admission (and therefore health facilities pressures) and death. Reducing the impact of exacerbations is very important. Investigators have previously shown that earlier treatment of COPD exacerbations results in faster recovery, and reduced chance of hospital admission. Helping patients to detect exacerbations early is therefore important. Investigators have also recently shown that monitoring heart rate and oxygen saturation via a finger probe may assist in this. However, measuring these variables when the patient is awake means they can be affected by other things, such as exercise and anxiety. Our new idea is that measuring heart rate and oxygen level overnight, when a patient is asleep, will give the best chance of detecting COPD exacerbations early and our study will test that. Investigators will randomly allocate 77 patients with COPD recruited from our service in London to standard monitoring, or overnight monitoring, for up to six months or the first exacerbation, whichever is sooner. Investigators will then analyse whether overnight monitoring was able to detect exacerbations earlier, and therefore could be used to help patients get treatment earlier. A subset of participants will also wear an activity monitor overnight for the first two weeks, so that Investigators can assess the effect (if any) of overnight awake periods (such as trips to the bathroom) on the heart rate and saturation recording.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient diagnosed with COPD (smoking history of ≥10 pack years and FEV1/VC < 0.7 post-bronchodilator).
  • Patient who had two or more self-reported moderate or severe COPD exacerbations in the past 12 months.
  • Patient who can use study equipment and attend appointments.
  • Can communicate in English.

排除标准

  • Patient who was diagnosed with obstructive sleep apnea (through a self-report and/or a result of Stop Bang and Epworth questionnaires).
  • Patient with co-morbidity preventing taking part.
  • Patients already involved in an ongoing research study.

研究组 & 干预措施

ETH

Experimental

Overnight monitoring

干预措施: Nonin (Device)

CTH

Other

Morning monitoring

干预措施: Nonin (Device)

结局指标

主要结局

The primary outcome is the difference in time to receive treatment from exacerbation onset as defined by symptoms, compared to exacerbation onset as defined by change in physiology

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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