NCT00547456终止不适用
Consequences of Nocturnal and Daytime Hypoxemia in COPD
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Demonstration of Improvement in Systemic Inflammation, Sleep Quality and Health Related Quality of Life With Nocturnal Oxygen Supplementation.
研究概览
简要总结
We will determine whether oxygen therapy lowers the level of substances in the blood which cause inflammation, which is one of the adverse effects of COPD and whether oxygen improves overall well being and quality of life as well as sleep quality.
详细描述
Hypothesis
Isolated nocturnal hypoxemia contributes to chronic systemic inflammation in COPD by activating circulating neutrophils.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males or females with a diagnosis of COPD screened for nocturnal desaturation as indicated above.
- •Clinical stability defined by absence of treatment change or need for acute care within the last two months.
- •Weight stable, within 5%, in the previous three months as measured during office visits.
- •Willingness to participate in a clinical study.
排除标准
- •Acute illness within the preceding 2 months.
- •Patients who received systemic glucocorticoid therapy within the past month.
- •Clinical and/or overnight pulse oximetry evidence of obstructive sleep apnea (OSA). The Multivariate Apnea Prediction Questionnaire (MAP) will be given to all patients to assess the likelihood of OSA based on common symptoms of this disorder. While we recognize that this screening instrument was not evaluated specifically in COPD patients, it assesses common signs and symptoms of OSA. This tool has been shown to identify OSA with 95% sensitivity (63). In addition, the ODI 4% will be determined from the overnight pulse oximetry recording. Patients will be excluded if the MAP score is > 0.4 or if the ODI 4% is >15/hour, which is suggestive of the concomitant presence of obstructive sleep apnea.
- •Hypercapnia defined as PaCO2 > 50 mmHg on resting arterial blood gas
- •Previous diagnosis of erythrocytosis, pulmonary vascular disease, pleural effusions, ischemic heart disease or congestive heart failure.
- •No chronic illnesses known to affect the inflammatory response such as infection, collagen vascular disease, liver disease, thyroid disease or diabetes.
- •Primary care or pulmonary physician refusal.
- •Patient refusal for any reason.
- •Lack of capacity to participate in the informed consent process.
研究组 & 干预措施
Decrease in oxygen level when sleeping
Other
Patients are their own controls and tested pre and post the addition of night time supplemental oxygen
干预措施: Oxygen (Drug)
结局指标
主要结局
Demonstration of Improvement in Systemic Inflammation, Sleep Quality and Health Related Quality of Life With Nocturnal Oxygen Supplementation.
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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