NCT02987179Unknown不适用
Identification of Desaturation Episodes by Means of Continuous Measurement of Oxygen Saturation During Hemodialysis
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Identifying Intradialytis desaturation episodes
研究概览
简要总结
The clinical diagnosis of sleep apnea is difficult among ESRD patients since the characteristic clinical features of sleep apnea may be absent and since sleep-related symptoms, such as fatigue and sleepiness, may be attributed to kidney failure. However, the evaluation of patients with possible sleep apnea is the same among ESRD patients as in the general population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years and able to give written informed consent to the study
- •On chronic hemodialysis for ≥ 90 days at time of enrollment
- •Ability to read
- •Consent to have video recording taken during study visit
排除标准
- •Subjects with cognitive impairment to consent
- •Sickle cell anemia
- •Prescription of nasal oxygen
- •Simultaneous participation in another clinical trial that may affect breathing frequency/patterns, blood oxygenation, sleep/wake cycle or other parameters related to the outcomes of interest to this study
- •Use of a breathing device, e.g. CPAP
- •Central venous catheter used as vascular access for hemodialysis
- •Artificial fingernails (may disturb the measurement of the WatchPAT)
- •Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study).
- •Permanent pacemaker
- •Sustained non-sinus cardiac arrhythmias.
结局指标
主要结局
Identifying Intradialytis desaturation episodes
时间窗: 1 week
• To determine the sensitivity and specificity of the CLM for identifying intradialytic desaturation episodes, using the WatchPAT device as the reference method.
次要结局
未报告次要终点
研究者
研究点 (1)
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