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临床试验/NCT02939586
NCT02939586已完成不适用

A Cross-sectional, Randomised-controlled Study to Investigate the Effect of HDF vs HD in Sleep Apnoea

John Hunter Hospital2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Severity of Sleep Apnea measured by Apnea-hypopnea index

研究概览

简要总结

Sleep disturbance is a significant issue in people undergoing dialysis. More than 80% of haemodialysis patients complain of difficulty sleeping. Inadequate sleep can cause poor daytime function and increased risk of motor vehicle incidents.

One of the common reasons for sleep disturbance in dialysis patients is sleep apnoea. Sleep apnoea involves pauses in breathing that occur during sleep. Each pause can last only a few seconds or minutes. Severe sleep apnoea reduces oxygen supply and increases risk of heart attack and stroke, which are the leading causes of death in dialysis patients.

In this project, the investigators will examine how a change of dialysis treatment might improve sleep. This project will first identify patients at risk of sleep disturbance using surveys and a subsequent sleep study. The investigators will then test different dialysis models to see the effect of dialysis treatment on sleep apnoea. The aim is to find a dialysis model that works better for patients with sleep apnoea.

详细描述

Sleep Problem in Dialysis Patients Sleep apnoea is a significant issue in patients with end stage kidney disease. Evidence suggests that up to 80% of dialysis patients have sleep apnoea [1], yet the standard haemodialysis treatment does not improve the symptoms of sleep disturbance in most patients [2].

Sleep disturbance is specifically associated with poor quality of life (QoL) [4]; decreased mental and physical function, and adversely impact survival [5-7]. Recent data also suggest that the low oxygen state resulting from sleep apnoea can exaggerate the deterioration of kidney function and increase risk of high blood pressure, cardiovascular abnormality and overall death rates [8]. Despite the significance of sleep apnoea, it is acknowledged that there is insufficient evidence for clinicians to manage this common symptom burden in the dialysis population [9]; and patients who receive maintenance dialysis today still experience poor QoL and worse survival rates compared with most common cancer sufferers [10].

Knowledge Gap It is believed that the mechanism of sleep apnoea in dialysis patients are related to overactive chemoreceptors, which cause destabilisation of the respiratory drive and periodic breathing during the night [13]. Since the chemoreceptors can be triggered by inflammatory blood toxins, which accumulate in kidney failure [14], it is proposed that better clearance of these molecules can improve symptoms and outcomes of sleep apnoea. These molecules are poorly removed by standard haemodialysis [15] and are thought to cause the symptomatic effects of poor kidney function and inflammation, which are associated with poor sleep quality [16].

Better dialysis treatment may play an important role in the management of sleep apnoea. Previous studies have suggested that sleep apnoea may be improved by nocturnal dialysis; an intensive treatment which patients undergo at home, during sleep, for 8-10 hours every night. It provides better blood purification, compared with standard haemodialysis treatment. However, nocturnal dialysis is a home therapy which is not viable for the majority of haemodialysis patients who require care in a clinical setting. There is clearly a need to explore the effectiveness of dialysis treatment on sleep apnoea using a different dialysis model.

Modern dialysis technology, such as Haemodiafiltration (HDF), allows for better removal of toxic molecules such as beta 2 microglobulin (B2M) and C-Reactive protein (CRP), than standard haemodialysis treatment, and may offer the benefits of nocturnal dialysis to all dialysis patients. No one has examined the effect of HDF on sleep apnoea in haemodialysis patients, and the investigators will answer this question in this study.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Severity of Sleep Apnea measured by Apnea-hypopnea index

时间窗: 18 months

The Apnea-Hypopnea Index (AHI) score will be used to determine the severity of sleep apnea. The AHI will be obtained via an overnight sleep study. An AHI score of 5-14.9/hr is classified mild sleep apnea, 15-29.9/hr is moderate and above 30/hr is severe sleep apnea.

次要结局

  • Patient-reported sleep quality measured by PSQI(18 months)
  • Overall quality of life measured by KDQoL-36(18 months)
  • The different concentration of inflammatory biomarkers (CRP, β2M, TNF-α, IL-6 and IL-8) during HDF period vs HD period, and the correlation to AHI, and overall sleep quality and quality of life.(18 months)
  • Patient-reported daytime sleepiness measured by ESS(18 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ginger Chu

Clinical Nurse Consultant

John Hunter Hospital

研究点 (2)

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