Efficacy of High Flow Therapy in COPD At Home
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Lung Function
研究概览
简要总结
Preliminary data show that in COPD patients, HFT substantially decreases ventilatory demand during sleep. The central hypothesis of this proposal is that lowering ventilatory demand using nasal high-flow therapy during sleep will elevate lung function, reduce dyspnea on exertion and improve quality of life. Thus, this proposal aims will determine the effects HFT over time on 1) lung function; 2) dyspnea on exertion; and 3) quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting adults over the age of 18 with COPD
排除标准
- •Apnea Hypopnea Index>15 events/hr
- •Use of Non-invasive positive pressure ventilation (CPAP + Bilevel)
- •Severe bilateral nasal obstruction (apparent mouth breathing at rest)
- •Documented clinical cardiovascular disease, as defined below:
- •myocardial infarction in past 3 months
- •revascularization procedure in past 3 months
- •implanted cardiac pacemaker or ICD
- •unstable arrhythmias
- •congestive heart failure with ejection fraction < 40%
- •uncontrolled hypertension (BP > 190/110)
- •History of end stage renal disease (on dialysis)
- •History of end stage liver disease, such as:
- •history of recurrent gastrointestinal bleeding
- •transjugular intrahepatic portosystemic shunt (TIPS) ;
- •Transportation industry worker (commercial truck or bus drivers, airline pilots)
- •Known pregnancy (by self report)
- •Known coagulopathy or anticoagulant use (e.g. coumadin) other than aspirin.
- •Do you take medications for any of the following reasons:
- •Pain control (besides NSAIDs)
- •Sleep medication
- •Benzodiazepines
结局指标
主要结局
Lung Function
时间窗: Baseline and 1 month
Spirometry will be performed before and after each sleep study
Quality of life
时间窗: Baseline and 1 month
St Georges Respiratory Questionnaire Hopkins Sleep Survey MRC Breathlessness Scale UCSD Shortness of Breath
Dyspnea score
时间窗: Baseline and 1 month
Borg scale score before and after each sleep study
Sleep quality
时间窗: Baseline and 1 month
Sleep architecture assessed from sleep studies
次要结局
未报告次要终点