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临床试验/NCT02020642
NCT02020642已完成不适用

Prospective Interventional Study Investigating the Effect of Renal Transplantation on Obstructive Sleep Apnea 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 40 人开始时间: 2013年10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
40
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 renal transplantation on fluid overload and its consequence on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease. 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 fluid overload, including chronic renal failure.

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

The severity of obstructive sleep apnea is measured by two attended polysomnographies, a baseline PSG performed before and a follow-up PSG performed 6 month after renal transplantation. Overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. Patients who are not already transplanted 6 months after the baseline PSG will be re-assessed and will be analyzed as control group.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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, with an apnea-hypopnea index (AHI) ≥ 15/h
  • age ≥ 18 years
  • patient with end stage renal disease on waiting list for a renal transplantation (cadaveric or live donor).

排除标准

  • unstable congestive heart failure
  • active psychiatric disease
  • amputation of the lower limbs, proximal to the ankle

研究组 & 干预措施

Intervention Group

Experimental

A baseline polysomnography (PSG) is performed at inclusion (before renal transplantation, Tx), followed by a post-Tx PSG 6 months after transplantation

干预措施: Renal transplantation (Procedure)

Control Group

No Intervention

A baseline polysomnography (PSG) is performed at inclusion, followed by a follow-up PSG at 6 months if the patient is not already transplanted

结局指标

主要结局

Reduction of the obstructive sleep apnea severity

时间窗: six months after renal transplantation

Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, six months after renal transplantation

次要结局

  • Relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea(at baseline and six months after renal transplantation)
  • Change in the severity of the periodic limb movement disorder (PLMD)(six months after renal transplantation)
  • Reduction in nocturnal leg fluid volume shift between the legs and the neck(six months after renal transplantation)
  • Change in the severity of central sleep apnea(six months after renal transplantation)

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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