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
- 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
- •Subject has ability to provide written informed consent
- •Subject aged ≥18 years old
- •Subject has a diagnosis of COPD, OHS or NMD with sleep hypoventilation (historical PtCO2 increase overnight ≥ 10mmHg) and/or daytime hypercapnia (>45 mmHg)
- •Subject is currently using non-invasive ventilation for ≥ 3 months
- •Subject with an AHI ≥ 5 hr. (as documented in diagnostic or pressure determination sleep study report)
排除标准
- •Subjects not compliant on NIV (ie. < 4 hr/night)
- •Subjects with severe asthma
- •Subjects who are pregnant
- •Subjects on oxygen therapy (ie. >4 L/min)
- •Subjects with a tracheostomy
- •Subjects who are acutely ill, medically complicated or who are medically unstable
- •Subjects in whom PAP therapy is otherwise medically contraindicated
- •Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
- •Subjects with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome.
- •Subjects who require ventilatory support during wakefulness
- •Subjects with the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, low blood pressure, cerebrospinal fluid leak, recent cranial surgery or trauma.
- •Subjects with severe developmental delay and who will not be able to follow tasks as instructed in the protocol.
- •Subjects who the investigator believes are unsuitable for inclusion because either:
- •they do not comprehend English
- •they are unable or unwilling to provide written informed consent
- •they are physically unable to comply with the protocol
- •they are unsuitable to participate in the trial for any other reason in the opinion of the investigator
研究组 & 干预措施
Standard ST Mode
Participants underwent the first PSG study (Titration Night 1) on ST Mode ( prior to going on AutoEPAP iVAPS or Fixed EPAP iVAPS) whilst receiving their standard NIV therapy through the clinical trial device "Juno". During this mode the participant's current NIV settings were reviewed and re-titrated to deliver optimal therapy.
干预措施: Juno (Device)
AutoEPAP iVAPS
Participants underwent a PSG study on the AutoEPAP iVAPS mode on either Night 2 or Night 3 according to their computer generated randomisation.
Participants were randomised (1:1) according to a computer-generated randomised list (Microsoft Excel 2010) to receive 'AutoEPAP iVAPS' or 'FixedEPAP iVAPS' therapy mode first.
干预措施: Juno (Device)
Fixed EPAP iVAPS
Participants underwent a PSG study on the Fixed EPAP iVAPS mode on either Night 2 or Night 3 according to their computer generated randomisation.
Participants were randomised (1:1) according to a computer-generated randomised list (Microsoft Excel 2010) to receive 'AutoEPAP iVAPS' or 'FixedEPAP iVAPS' therapy mode first.
干预措施: Juno (Device)
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)