Effect of Hemodiafiltration on Sleep-Disordered Breathing in Patients With End-Stage Renal Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Reduction in apnea hypopnea index after a treatment period of three months of hemodiafiltration; scored on overnight polysomnography
研究概览
简要总结
The purpose of this study is to determine whether hemodiafiltration, a new form of hemodialysis can improve sleep apnea in patients with end stage kidney disease.
详细描述
Sleep apnea or breathing problems during sleep are frequent, occurring in 6% of the general population. However, more than half of all patients on dialysis suffer from breathing problems related to sleep. Sleep apnea is associated with high blood pressure, excessive sleepiness, fatigue, poor memory and concentration as well as depression in those with normal kidneys.
Hemodiafiltration is a new kind of dialysis that is more efficient at clearing toxins that accumulate in kidney failure. It has been used successfully in Europe for over 15 years. However, the effects of hemodiafiltration on sleep apnea in dialysis patients have never been assessed.
We are conducting a clinical trial to examine the effects of hemodiafiltration on sleep apnea in dialysis patients. Fifteen patients with sleep apnea, already on dialysis will be treated with hemodiafiltration 3 times a week, instead of their regular hemodialysis treatment for a period of 3 months. We will repeat sleep studies in these patients before and after the hemodiafiltration period and assess their quality of life.
We hope to decrease the severity of sleep apnea with hemodiafiltration. This could result in better sleep, improved energy level, mood, memory, concentration and blood pressure control in those afflicted by sleep apnea and on dialysis. Our findings would also give us better insight into the cause of sleep apnea in patients with end stage kidney disease.
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
- Single
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
- •Patients currently stable on a thrice weekly hemodialysis regimen for a minimum of 3 months
- •Patients with vascular access and no contraindications to anticoagulation
- •Presence of sleep-related breathing disorder defined as a mean apnea-hypopnea per hour of recording greater than 10 based on cardiorespiratory monitoring
排除标准
- •Patients already on hemodiafiltration therapy
- •Patients already on treatment for sleep disordered breathing.
- •Patients with significant neuromuscular disease
- •Patients with an expected lifespan < 1 year
- •Patients unable to complete sleep related quality of life questionnaires and consent forms due to language barriers or dementia
- •Patients with known substance abuse
- •Patients with a respiratory disturbance index greater than 30 with active cardiovascular disease defined by unstable angina, myocardial infarction within 3 months or an Epworth sleepiness score greater than 15 while actively working in a stress situation (for example bus driver, taxi driver). These patients will be evaluated by a sleep specialist.
- •Living further than 30 km from dialysis centre
结局指标
主要结局
Reduction in apnea hypopnea index after a treatment period of three months of hemodiafiltration; scored on overnight polysomnography
次要结局
- Generic Quality of life
- specific quality of life related to sleep apnea
- specific quality of life related to Restless leg syndrome
- 24 hour blood pressure control
- Periodic limb movement indices
- Validity of a positive screening sleep study
- specific quality of life related to sleep
- Upper airway neuronal afferent dysfunction
- Relationship between cytokine levels and sleep apnea severity
- Relationship between dialysis clearance and sleep apnea severity