Treatment of Obstructive Sleep Apnea in Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 主要终点
- eGFR (estimated glomerular filtration rate)
研究概览
简要总结
This study is being conducted to determine whether treatment of obstructive sleep apnea (OSA) in patients with chronic kidney disease (CKD) improves kidney function. Half of the participants will receive continuous positive airway pressure (CPAP) treatment for their OSA in addition to their regular CKD treatment, while the other half will only receive their regular CKD treatment.
详细描述
Obstructive sleep apnea (OSA) and associated hypoxemia during sleep have been associated with a decline in kidney function. The abnormalities in kidney function associated with OSA have been improved by treatment of OSA with continuous positive airway pressure (CPAP), which is a common and effective therapy for OSA. Up to now, clinical research on the impact of OSA on kidney function has been performed on patients without CKD. This study will examine the impact of CPAP therapy on kidney function in patients with CKD.
CKD patients with OSA and nocturnal hypoxemia will be randomized into one of two groups where half will receive treatment of their OSA with CPAP and the other half will not. All participants will have kidney function monitored every 3 months for a year by measurement of serum creatinine and proteinuria. The change in estimated glomerular filtration rate (eGFR) and proteinuria between the two groups will be assessed to determine whether treatment of OSA improves kidney function in patients with CKD.
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
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD stage 3 or 4
- •OSA (RDI>5) and nocturnal hypoxemia (SaO2 <90% for >12% of night)
排除标准
- •Failure to meet inclusion criteria
- •Current therapy with CPAP or supplemental oxygen
- •Severe daytime sleepiness reflected by an Epworth Sleepiness Score >15
- •Any driver who holds a commercial drivers' license or who reports a recent history (past 6 months) of a road traffic accident
- •Severe nocturnal hypoxemia reflected by mean SaO2 <80% during level 3 sleep testing
- •Daytime hypoxemia reflected by partial pressure of oxygen in arterial blood (PaO2) less than 60 millimetres of mercury (mmHg) during wakefulness
- •Hypoventilation reflected by partial pressure of carbon dioxide in arterial blood (PaCO2) greater than 45 millimetres of mercury (mmHg) during wakefulness
- •Central sleep apnea that accounts for >50% of the estimated RDI
- •Unable to provide informed consent
结局指标
主要结局
eGFR (estimated glomerular filtration rate)
时间窗: 12 months
Change in eGFR in CPAP group compared to control group.
次要结局
- Pittsburgh Sleep Quality Index (PSQI)(12 months)
- Epworth Sleepiness Scale (ESS)(12 months)
- ACR (albumin/creatinine ratio)(12 months)
- Kidney Disease Quality of Life questionnaire (KDQoL)(12 months)
研究者
Dr. Patrick Hanly
Principal Investigator
University of Calgary