Indication and Benefits of Nocturnal Oxygen Therapy in Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- the improvement in nocturnal hypoxemia by the measurement of nocturnal pulse oximetry (SpO2) after 6 weeks of nocturnal oxygen therapy in stable patients with CF
研究概览
简要总结
This is an open, multicenter, prospective, randomised and cross over study, comparing in patients with cystic fibrosis aged > 6 years, 2 periods of 6 weeks of oxygen therapy or room air, separated by a wash out period of 2 to 6 weeks.
详细描述
Rationale Oxygen therapy may be proposed to patients with cystic fibrosis (CF) with nocturnal hypoxemia but the indication and benefits of oxygen therapy have not been validated in CF.
Aim of the study and main objective The aim of the study is to evaluate the improvement in nocturnal hypoxemia by the measurement of nocturnal pulse oximetry (SpO2) after 6 weeks of nocturnal oxygen therapy in stable patients with CF.
An improvement is defined by a nocturnal SpO2 > 90% during the whole night.
Objectives and secondary aims
- Comparison of subjective sleep quality during oxygen therapy and room air after a period of 6 weeks by means of 4 validated sleep questionnaires
- Comparison of quality of life during oxygen therapy and room air after a period of 6 weeks by means of a validated questionnaire for CF patients (CFQ).
- Detection of the appearance or increase in nocturnal hypercapnia during oxygen therapy and room air after a period of 6 weeks
- Comparison of a possible arterial pulmonary hypertension during oxygen therapy and room air after a period of 6 weeks by means of an echocardiography
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ≥ 6 years and adults ≥ 18 years with CF in a stable state
- •With a forced expiratory volume in one second (FEV1) ≤ 50% of predicted value
- •Having a pulse oximetry (SpO2) in room air ≤ 90% for ≥ 10% of the night and/or a SpO2 ≤ 90% for ≥ 10 minutes during the night
- •Any patient with prior noninvasive positive pressure ventilation (NPPV) but who has stopped NPPV at least 15 days before the start of the study.
- •Written approval by the patient and by the parents in case of a pediatric patient
- •Patient having the French social security coverage
排除标准
- •Patients with a respiratory exacerbation during the last 15 days
- •Patients with NPPV or long term oxygen therapy prior to the start of the study and unable to stop this treatment
- •Impossibility of a medical examination
- •Pregnant patient or breastfeeding patient
结局指标
主要结局
the improvement in nocturnal hypoxemia by the measurement of nocturnal pulse oximetry (SpO2) after 6 weeks of nocturnal oxygen therapy in stable patients with CF
时间窗: after a 6 weeks period
次要结局
- Comparison of subjective sleep quality during oxygen therapy and room air after a period of 6 weeks by means of 4 validated sleep questionnaires(after a 6 weeks period)
- Comparison of quality of life during oxygen therapy and room air after a period of 6 weeks by means of a validated questionnaire for CF patients (CFQ).(after a 6 weeks period)
- Detection of the appearance or increase in nocturnal hypercapnia during oxygen therapy and room air after a period of 6 weeks(after a 6 weeks period)
- Comparison of a possible arterial pulmonary hypertension during oxygen therapy and room air after a period of 6 weeks by means of an echocardiography(after a 6 weeks period)