The Evaluation of the Sleep-Breathing Treatment Algorithm: AutoEPAP iVAPS
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- ResMed
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Apnoea-Hypopnoea Index (AHI)
研究概览
简要总结
This study is to evaluate the efficacy of a new therapy (Automatic Expiratory Positive Airway Pressure with intelligent Volume Assured Pressure Support (AutoEPAP iVAPS)) designed to treat respiratory insufficiency, respiratory failure and/or nocturnal hypoventilation with upper airway obstruction. The study will be performed in two phases: In a sleep unit and in the home environment. The new therapy will be compared against two existing ventilator therapies: "Spontaneous Timed (ST) mode" and "Intelligent Volume Assured Pressure Support (iVAPS)".
详细描述
Phase I: AutoEPAP iVAPS will be compared against two existing ventilator therapies: "Spontaneous Timed (ST) mode" and "Intelligent Volume Assured Pressure Support (Fixed EPAP iVAPS)" in current NIV users with respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD),Obesity Hypoventilation Syndrome (OHS) or Neuromuscular Disease (NMD). Patients will spend a total of 3 nights in the sleep laboratory in the three modes described above. The apnoea-hypopnoea index will be the primary outcome measure.
Phase II: AutoEPAP iVAPS will be compared to ST mode over a period of 7 nights in the patients' home. The mean EPAP setting of each device will be the primary outcome measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Apnoea-Hypopnoea Index (AHI)
时间窗: 1 night
The number of apneas and hypopnoeas per hour of sleep measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS
次要结局
- Mean Oxygen Saturation(1 night)
- Total Sleep Time Spent in Each Sleep Stage(1 Night)
- Number of Respiratory Event Related Arousals/ Hour(1 Night)
- Oxygen Desaturation Index(1 night)
- Sleep Duration(1 Night)
- Sleep Efficacy(1 Night)
- Sleep Latency-Wake After Sleep Onset Time(1 Night)
- Time Spent Below 90% Oxygen Saturation(1 night)
- Number of Spontaneous Arousals/Hour(1 Night)
- Mean Transcutaneous Carbon Dioxide (PtcCo2)(1 night)