Effect of Hemodialysis on Upper Airways Collapsibility in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Collapsibility of the upper airway.
研究概览
简要总结
Introduction: Currently, chronic kidney disease (CKD) is one of the most serious public health problems, becoming a global epidemic. It is also known that the amount of displacement of overnight rostral fluid, from the lower limbs, is related to increased neck circumference and severity of obstructive sleep apnea (OSA) in patients with end-stage renal disease. Method / Design: A clinical trial study aiming to assess the degree of collapsibility of the upper airway in patients with CKD undergoing hemodialysis has been proposed. The test of the negative expiratory pressure and nocturnal polysomnography will be performed before and after the hemodialysis session. Discussion: The incidence of CKD has increased, due to the increased number of cases of diabetes mellitus and hypertension. Our hypothesis is that the weight gain due to volume overload, observed in the interdialytic period, will exert a negative influence on the degree of collapsibility of the upper airways predispose to OSA in CKD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female patients aged 18 to 80 years;
- •chronic kidney failure;
- •candidate for kidney transplant with indication for dialysis;
- •cognitive level sufficient for understanding the procedures and following the instructions;
- •absence of dementia or treatment-refractory psychiatric diseases leading to an inability to provide informed consent.
- •and agreement to participate by signing a statement of informed consent.
排除标准
- •craniofacial abnormalities;
- •undergoing active treatment of sleep apnea;
- •active malignancy;
- •active alcohol and/or drug abuse;
研究组 & 干预措施
Hemodialysis
Chronic kidney disease patients undergoing hemodialysis will be recruited consecutively and screened for eligibility using a standardised protocol.
干预措施: Hemodialysis (Procedure)
结局指标
主要结局
Collapsibility of the upper airway.
时间窗: 06 months
Degree of upper airway collapsibility through the negative expiratory pressure test in patients with chronic kidney disease on hemodialysis.
次要结局
- Change in pulmonary function.(06 months)
- Prevalence and severity of sleep disorders(06 months)
研究者
Luis Vicente Franco de Oliveira
PhD
Centro Universitário de Anapolis