Pathogenesis and Outcomes of Sleep Disordered Breathing in COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- The evening to morning differences in expiratory airflow obstruction (FEV1/FVC)
研究概览
简要总结
This research is being conducted to examine the effects of nasal insufflation of warm and humidified air through a small nasal cannula on sleep, breathing pulmonary function, and daytime exercise capability.
详细描述
Chronic obstructive pulmonary disease (COPD) is associated with significant morbidity including substantial daytime fatigue exertional intolerance and ventilatory impairment, which hits a nadir in the morning. Nocturnal disturbances in sleep and breathing are common in COPD, although the impact of these disturbances on COPD morbidity remains largely unknown. The hypothesis is that COPD induces specific sleep and breathing disturbances that remain a substantial source of morbidity in this disorder.
Current therapy for treating nocturnal disturbances in sleep and breathing in COPD including nocturnal oxygen has failed to improve morning fatigue and pulmonary function. This study promises to significantly alter our approach to the diagnosis and management of sleep disordered breathing in COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consenting adults over the age of 21
- •BMI < 40 kg/m2
排除标准
- •Diagnosed with sleep apnea (apnea and hypopneas of >10 events/hr).
- •A sleep efficiency of <30%, or a prior diagnosis of disorders that impair sleep architecture.
- •Unstable cardiovascular disease (decompensated heart failure, myocardial infarction within the past 3 months, revascularization procedure within the past 3 months, unstable arrhythmias, uncontrolled hypertension (BP > 190/110)).
- •Severe renal insufficiency requiring dialysis.
- •Liver cirrhosis.
- •A recent acute illness in a 6 weeks period prior to the sleep studies.
- •We will exclude subjects with severe daytime hypoxemia (Oxyhemoglobin saturation (SaO2) <80% or partial pressure of oxygen (PaO2) <55 mmHg at rest).
- •Chronic use of sedatives or respiratory depressants that would affect sleep quality (e.g., benzodiazepines or other hypnotics or narcotics).
- •Pregnancy.
- •Tracheostomy or other significant oropharyngeal or nasopharyngeal surgery, in the last 6 months.
- •Narcolepsy and other neurological disorders such as Parkinson's Disease.
- •Severe hepatic insufficiency.
- •Bleeding disorders or Coumadin use.
- •Allergy to lidocaine or benzocaine.
- •Language/dementia/psychiatric issues - the participant must be able to provide consent.
结局指标
主要结局
The evening to morning differences in expiratory airflow obstruction (FEV1/FVC)
时间窗: 4 years
Lung function declines over the course of the night. We hypothesize that delivering warm and humidified air at a rate of 20 L/min over the entire night improves morning FEV1 compared to oxygen.
次要结局
- The percent rate of inspiratory flow limitation.(4 Years)
- Effect of High flow nasal insufflation of air on exercise capacity (6 minute walk test).(One Year)
研究者
Hartmut Schneider
Assistant Professor
Johns Hopkins University