Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome in End Stage Renal Disease Patients (SASinHD)
Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome and Its Correlation to Nocturnal Rostral Fluid Shift, in End Stage Renal Disease Patients
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
注册 (实际的)
阶段
- 不适用
联系人和位置
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
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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
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
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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.