Effects of Compression Stockings on Obstructive Sleep Apnea and Autonomic Nervous System in Patients Under Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change of Obstructive Apnea Severity Index Score From Baseline
研究概览
简要总结
To study the effects of compression stockings on sleep apnea in hemodialysis patients with diagnosed obstructive sleep apnea. The rationale of this study consists in the fluid shift theory, which consists in the nocturnal rostral fluid shift from legs, which causes upper airways edema.
The aim of this study is to evaluate if compression stockings could improve such nocturnal volume redistribution and, therefore, improve obstructive sleep apnea.
详细描述
Investigators will apply the following methods:
- Sleep study, performed through polysomnography
- Fluid redistribution, by bioimpedance analysis
- Autonomic nervous system evaluation, by spectral heart rate variability analysis.
The study protocol comprises two moments: baseline evaluation (in patients with diagnosed sleep apnea) and after using compression stockings for a one-week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under hemodialysis
- •Patients with diagnosed obstructive sleep apnea
排除标准
- •Congestive heart failure
- •Urine output > 500 ml/day
- •non-sinusal cardiac rhythm
- •refusal to give written consent
结局指标
主要结局
Change of Obstructive Apnea Severity Index Score From Baseline
时间窗: 1 week
Apnea/Hypopnea index (AIH) was assessed by a validated polysomnography (EMBLA®S4500, Embla Systems Inc., Broomfield, CO, USA) at baseline and 1 week after compression stockings use. The observed results are expressed as median and interquartile range (25,75 percentiles): * AIH at baseline: 20.8 (14.2; 39.6) events/hour; * AIH after compression stockings use: 16.7 (3.5; 28.9) events/hour
次要结局
- Change in Fluid Distribution From Baseline(1 week)
- Change of Heart Rate Variability Change From Baseline(1 week)
研究者
Bruno Caldin da Silva
MD
University of Sao Paulo