Effect of Intermittent Hemodialysis on Sleep Apnea Syndrome and Its Correlation to Nocturnal Rostral Fluid Shift, in End Stage Renal Disease Patients
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
- 否
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
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
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
Adam Ogna
Centre d'Investigation et Recherche sur le Sommeil (CIRS)
Centre Hospitalier Universitaire Vaudois
