跳至主要内容
临床试验/NCT00218790
NCT00218790已完成不适用

The Effects of Hemodialysis on the Sleep/Wake Cycle

Emory University2 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2003年4月1日最近更新:
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
58
试验地点
2
主要终点
total sleep time

研究概览

简要总结

A major component of this study is to test a novel application for a safe, non-pharmacologic, cost-effective intervention that is already in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis patients. We will also evaluate its effects on selected sleep-related physiologic, psychological, behavioral, and general health outcomes.

详细描述

Preliminary results demonstrate that, after one treatment, using cool dialysate instead of warm dialysate markedly normalized the rhythm of body temperature and improved indices on nocturnal sleep quantity and quality. Therefore, a major component of this study is to test a novel application for a safe, non-pharmacologic, cost-effective intervention that is alreay in use in clinical practice - using cool dialysate during hemodialysis to help stabilize the sleep/wake cycle of chronic hemodialysis patients. We will also evaluate its effects on selected sleep-related physiologic, psychological, behavioral, and general health outcomes.

To test the efficacy of this intervention, a randomized, single-blinded, pretest-posttest, control group design is being used. The major independent variable is dialysate temperature. The major dependent variables are measures of sleep, body temperature, rest/activity patterns, and general health outcomes.

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 (Investigator)

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All races, cause of renal failure is diabetes, hypertension, glomerulonephritis, or polycystic kidney disease; ability to read and write in English; clinically stable.

排除标准

  • •Current use of sleeping medication; history of alcoholism or drug abuse; brain disease; severe hypertension; severe heart disease; low functional level

研究组 & 干预措施

Control group

No Intervention

The control group received standard dialysis at a temperature of 37 degrees Celcius

Experimental group

Experimental

Subjects in the experimental group received cool dialysate during treatment

干预措施: Cool Dialysate (Procedure)

结局指标

主要结局

total sleep time

时间窗: 9months

amount of time slept per night

次要结局

  • quality of life(9 months)

研究者

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

Kathy P. Parker, PhD, RN, FAAN

Principal Investigator

Emory University

研究点 (2)

Loading locations...

相似试验