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Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome in End Stage Renal Disease Patients (SASinHD)

2013年12月19日 更新者:Adam Ogna、Centre Hospitalier Universitaire Vaudois

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Vaud
      • Lausanne、Vaud、瑞士、1011
        • Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV)

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Group A
the first polysomnography (PSG) is performed before hemodialysis (HD), followed by a post-HD PSG on the subsequent night
Intermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study)
实验性的:Group B
the first PSG is performed after hemodialysis (HD), followed by a pre-HD PSG, on the subsequent night
Intermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Reduction of the obstructive sleep apnea severity
大体时间: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
two nights (before and after an ambulatory hemodialysis session)

次要结果测量

结果测量
措施说明
大体时间
Reduction in nocturnal leg fluid volume shift between the legs and the neck
大体时间:two nights (before and after an ambulatory hemodialysis session)
Reduction in nocturnal leg fluid volume shift between the legs and the neck, measured by bioimpedance and neck circumference after an ambulatory hemodialysis session
two nights (before and after an ambulatory hemodialysis session)
relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome
大体时间:one night
relationship between overhydration (measured by bioimpedance), leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea syndrome
one night
severity of the periodic limb movement disorder (PLMD)
大体时间:two nights (before and after one hemodialysis session)
severity of the periodic limb movement disorder (PLMD)
two nights (before and after one hemodialysis session)
severity of central sleep apnea syndrome
大体时间:two nights (before and after one hemodialysis session)
severity of central sleep apnea syndrome
two nights (before and after one hemodialysis session)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Raphael Heinzer, MD、Centre d'Investigation et Recherche sur le Sommeil (CIRS) - Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年3月1日

初级完成 (实际的)

2013年10月1日

研究完成 (实际的)

2013年10月1日

研究注册日期

首次提交

2013年5月18日

首先提交符合 QC 标准的

2013年5月18日

首次发布 (估计)

2013年5月22日

研究记录更新

最后更新发布 (估计)

2013年12月20日

上次提交的符合 QC 标准的更新

2013年12月19日

最后验证

2013年12月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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