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临床试验/NCT02825589
NCT02825589已完成不适用

Effect of Bioelectrical Impedance Analysis-Guided Comparing With Standard Clinical-Guided Dry Weight Assessment on Sleep Quality in Chronic Hemodialysis Patients

Mahidol University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2016年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Change of sleep actigraphy parameters

研究概览

简要总结

Based on many previous data proving hypervolemia in chronic hemodialysis patients could lead to sleep apnea and poor sleep quality. The investigators conduct this trial to evaluate whether more accurate dry weight assessment with BIA in these patients can lead to better sleep quality (measured by sleep actigraphy and questionnaires). The investigators will enroll 30 chronic hemodialysis patients in hemodialysis unit of Ramathibodi hospital whose age > 18 years with subclinical hypervolemic status and baseline Pittsburgh sleep quality index (PSQI) score > 5 into study. Patients with bed-ridden status, alteration of consciousness and unstable hemodynamics will be excluded. Then eligible patients will be randomized into 2 groups, BIA-guided and standard clinical guided dry weight assessment. The investigators will assess participants' dry weight at beginning of study, 3rd month and 6th month. Sleep actigraphy parameters (eg. total sleep time, sleep efficiency), sleep questionnaires score, left ventricular mass index by echocardiography, ambulatory blood pressure monitoring and blood chemistry results were collected at beginning of study, the end of 1st, 3rd and 6th month. The primary outcome is change of sleep actigraphy parameters between the groups. The secondary outcomes are change of sleep questionnaires scores, change of left ventricular mass index, change of ambulatory BP monitoring and also cardiovascular complications between groups.

详细描述

This randomized control trial aim to detect the better volume control guided by bioimpedance may improve ambulatory blood pressure control, sleep quality and left ventricular hypertrophy.

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
Single (Participant)

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

  • regular hemodialysis 3 times/week
  • PSQI score >5
  • Subclinical hypervolemia

排除标准

  • bed ridden status
  • alteration of consciousness
  • unstable hemodynamics

研究组 & 干预措施

BIA-guided

Experimental

Assessment of target dry weight guided by using bioelectrical impedance analysis (BIA).

干预措施: BIA (Device)

Standard clinical guided

No Intervention

Assessment of target dry weight guided by clinical evaluation eg. jugular venous pressure, blood pressure, edema etc.

结局指标

主要结局

Change of sleep actigraphy parameters

时间窗: 6 months

total sleep time, sleep efficiency, fragmentation index

次要结局

  • Change of ambulatory blood pressure monitoring(6 months)
  • Cardiovascular complications(6 months)
  • Change of PSQI scores(6 months)
  • Change of left ventricular mass index by echocardiography(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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