NCT05857475已完成不适用
Efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome
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
- 10
- 试验地点
- 1
- 主要终点
- 6 minute walking test distance
研究概览
简要总结
To evaluate efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome
详细描述
To evaluate efficacy of CPAP Therapy on Pulmonary Function Test in Patients With COPD-OSA Overlap Syndrome by 6 minute walking distance and oxygen consumption.
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis with COPD by GOLD guideline criteria (Post bronchodilator FEV1/FVC < 0.7 or < LLN) with post bronchodilator FEV1 = 30-80%
- •Diagnosis with obstructive sleep apnea with AHI > 15 event/hr. (Moderate OSA or more)
- •Age between 40-80 years
- •Stable disease prior to inclusion.
排除标准
- •Diagnosis with > 50% of central sleep apnea event
- •History of COPD exacerbation during the past 8 week prior to inclusion.
- •Subjects who cannot perform spirometry test or walking test
- •Subjects with recording history of chronic heart failure, significant arrhythmias, acute myocardial infarction, moderate to severe mitral or aortic valve disease and pulmonary hypertension.
- •Subjects with interstitial lung disease.
- •Subjects with neuromuscular disease.
- •Subjects with morbid obesity (BMI >/=35)
- •Subjects with chronic respiratory infection.
- •Subjects with chronic CO2 retension (PaCO2 >/= 45 from arterial blood gas analysis) or Transcutaneous CO2 during sleep test >/= 45 or Serum bicarbonate level > 27
- •Subjects with acute or active respiratory infecton during 2 week prior to inclusion.
研究组 & 干预措施
CPAP therapy
Experimental
CPAP therapy will be used in this arm for 2 month.
干预措施: CPAP therapy (Device)
Control
Other
CPAP therapy will not be used in this arm for 2 month. (subject were assign to normal waiting list in order to borrowing hospital PAP machine.)
干预措施: Control (Other)
结局指标
主要结局
6 minute walking test distance
时间窗: 2 months
To measure distance subject could walk during the period of 6 minute
次要结局
- Quality of life by Sleep quality questionaires: Pittsburgh Sleep Quality Index (PSQI)(2 months)
- Quality of life by questionaires: modified British Medical Research Council Dyspnea Scale (mMRC)(2 months)
- Quality of life by questionaires: COPD Assessment Test (CAT)(2 months)
- Quality of life by questionaires: St. George's Respiratory Questionnaire (SGRQ)(2 months)
- Quality of life by Sleep quality questionaires: Functional Outcomes of Sleep Questionnaire (FOSQ)(2 months)
- Quality of life by Sleep quality questionaires: Epworth Sleepiness Scale (ESS)(2 months)
- Quality of life by Sleep quality questionaires: Lausanne NoSAS (Neck circumference, Obesity, Snoring, Age, Sex) score(2 months)
- Aerobic capacity(2 months)
研究者
研究点 (1)
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