The Effect of Continuous Positive Airway Pressure Therapy on Lung Hyperinflation in Patients With Obstructive Sleep Apnoea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of Vital Capacity (VC) (ml)
研究概览
简要总结
Assessment of the lung hyperinflation by bodypletysmography in patients with obstructive sleep apnoea treated with continuous positive airway pressure therapy.
详细描述
Rationale:
Obstructive sleep apnoea (OSA) is characterized by repetitive closure of upper airways leading to apnoea (complete airflow cessation) or hypopnoea (airflow limitation > 50% + blood oxygen desaturation > 3% or airflow limitation > 30% blood oxygen desaturation > 4%). The prevalence of lung hyperinflations in sleep apnoea patients and effect of continuous positive airway pressure (CPAP) therapy is not known.
Process:
Subjects included in the study will be obstructive sleep apnoea (OSA) patients diagnosed by respiratory polysomnography performed in the Sleep Laboratory, Department of Respiratory Medicine, University Hospital Olomouc.
Bodypletysmography will be performed in the time of OSA diagnosis and after 3 months of CPAP therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Obstructive sleep apnoea syndrome indicated for CPAP therapy (Apnoea- Hypopnoea index ˃ 15)
排除标准
- •- Bilevel positive airway pressure therapy
- •Total lung capacity < 80% lower limit of normal values
- •Obstructive ventilatory disorder
- •Change in body weight ˃ 10%
- •Change in smoking status
结局指标
主要结局
Change of Vital Capacity (VC) (ml)
时间窗: 3 months
Percentage change of Vital Capacity after 3 months of CPAP therapy.
Change of Forced Expiratory Volume in 1 second (FEV1) (ml)
时间窗: 3 months
Percentage change of Forced Expiratory Volume in 1 second after 3 months of CPAP therapy.
Change of Total Lung Capacity (TLC) (ml)
时间窗: 3 months
Percentage change of Total Lung Capacity after 3 months of CPAP therapy.
Change of Residual Volume (RV) (ml)
时间窗: 3 months
Percentage change of Residual Volume after 3 months of CPAP therapy.
次要结局
未报告次要终点
研究者
Milan Sova
Principal Investigator, Head of Sleep Laboratory, Department of Respiratory Medicine
University Hospital Olomouc