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临床试验/NCT01860209
NCT01860209已完成不适用

Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome and Its Correlation to Nocturnal Rostral Fluid Shift, in End Stage Renal Disease Patients

Centre Hospitalier Universitaire Vaudois2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年3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
20
试验地点
2
主要终点
Reduction of the obstructive sleep apnea severity

研究概览

简要总结

The purpose of this study is to investigate the effect of decreasing fluid overload by hemodialysis on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease on intermittent hemodialysis. It aims further to investigate the relationship between overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.

详细描述

Obstructive sleep disordered breathing is more prevalent in end stage kidney disease patients than in the general population, and may participate to the increased cardiovascular mortality observed in this group of patients. Despite a significant increase in knowledge about the harmful effects of obstructive sleep apnea, the pathophysiological mechanisms are poorly understood. Recent observations suggest a causative relationship between overnight fluid displacement from the legs to the neck soft and the severity of obstructive sleep apnea. This mechanism was demonstrated in otherwise healthy subjects, in heart failure patients, and in patients with venous insufficiency. We thus suspect that this pathophysiologic mechanism could explain the increased prevalence of obstructive sleep apnea in patients with hypervolemia, including chronic renal failure.

The purpose of this trial is to investigate the hypothesis that nocturnal rostral fluid ship is linked to overhydration and participates significantly to the severity of obstructive sleep apnea in patients on hemodialysis. The correction of overhydration by hemodialysis should therefore reduce the amount of nocturnally displaced water and consequently lower the severity of obstructive sleep apnea.

The severity of obstructive sleep apnea is measured by two consecutive attended polysomnographies, performed before and after an ambulatory hemodialysis session with fluid removal, whereas overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. The sequence of the two polysomnographies with respect to hemodialysis is randomized, to minimize the first-night effect.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • moderate to severe obstructive sleep apnea syndrome, with an apnea-hypopnea index (AHI) ≥ 15/h
  • age ≥ 18 years
  • patient with end stage renal disease on chronic intermittent hemodialysis
  • Exclusion criteria:
  • unstable congestive heart failure
  • pace-maker
  • active psychiatric disease
  • amputation of the lower limbs, proximal to the ankle

排除标准

  • 未提供

研究组 & 干预措施

Group A

Experimental

the first polysomnography (PSG) is performed before hemodialysis (HD), followed by a post-HD PSG on the subsequent night

干预措施: Hemodialysis (Procedure)

Group B

Experimental

the first PSG is performed after hemodialysis (HD), followed by a pre-HD PSG, on the subsequent night

干预措施: Hemodialysis (Procedure)

结局指标

主要结局

Reduction of the obstructive sleep apnea severity

时间窗: two nights (before and after an ambulatory hemodialysis session)

Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, after an ambulatory hemodialysis session

次要结局

  • severity of central sleep apnea syndrome(two nights (before and after one hemodialysis session))
  • relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome(one night)
  • Reduction in nocturnal leg fluid volume shift between the legs and the neck(two nights (before and after an ambulatory hemodialysis session))
  • severity of the periodic limb movement disorder (PLMD)(two nights (before and after one hemodialysis session))

研究者

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

Adam Ogna

Centre d'Investigation et Recherche sur le Sommeil (CIRS)

Centre Hospitalier Universitaire Vaudois

研究点 (2)

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