Prospective Interventional Study Investigating the Effect of Beginning a Renal Replacement Therapy on Obstructive Sleep Apnea and Its Correlation With Overhydration, in End Stage Renal Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- obstructive sleep apnea severity
研究概览
简要总结
The purpose of this study is to investigate the effect of beginning a renal replacement therapy 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
The prevalence of obstructive sleep apnea increases with progressing renal insufficiency. Recent observations suggest a causative relationship between overnight fluid displacement from the legs to the neck soft tissues and the severity of obstructive sleep apnea. We suspect that this pathophysiologic mechanism could explain the increased prevalence of obstructive sleep apnea in patients with fluid overload, including chronic renal failure.
The beginning of a renal replacement therapy modify the fluid balance of the end stage renal disease patients and could therefore impact on the severity of sleep apnea in this population.
The purpose of this trial is to investigate the hypothesis that the transition from untreated end stage renal disease and a renal replacement therapy decreases the severity of sleep apnea, by a reduction of the fluid overload and of the nocturnal rostral fluid shift.
The severity of obstructive sleep apnea is measured by two attended polysomnographies (PSG), a baseline PSG performed before and a follow-up PSG performed 6 month after beginning of a renal replacement therapy. Overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. Patients who have not yet begun a renal replacement therapy 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
- Treatment
- 盲法
- Single (Outcomes Assessor)
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, with an apnea-hypopnea index (AHI) ≥ 15/h
- •age ≥ 18 years
- •patient with end stage renal disease without renal replacement therapy.
排除标准
- •unstable congestive heart failure
- •active psychiatric disease
- •amputation of the lower limbs, proximal to the ankle
结局指标
主要结局
obstructive sleep apnea severity
时间窗: six months (before and after beginning of a renal replacement therapy)
Reduction of the obstructive sleep apnea severity, measured by attended polysomnography, six months after beginning of a renal replacement therapy
次要结局
- severity of central sleep apnea syndrome(six months (before and after renal beginning of a renal replacement therapy))
- nocturnal leg fluid volume shift(six months (before and after beginning of a renal replacement therapy))
- periodic limb movement disorder (PLMD)(six months (before and after beginning of a renal replacement therapy))
- relationship between overhydration, leg fluid volume shift, ankle and neck circumference and the severity of obstructive sleep apnea(one night)
研究者
Adam Ogna
Centre d'Investigation et Recherche sur le Sommeil (CIRS)
Centre Hospitalier Universitaire Vaudois