Comparison of Modified Adaptive Servoventilation Therapy With Conventional Adaptive Servoventilation Therapy in Patients With Periodic Breathing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Apnea/Hypopnea Index (AHI)
研究概览
简要总结
This study will determine if modified adaptive servoventilation (ASV) is as effective as the conventional ASV in treating periodic breathing. The study will determine if the modified ASV reacts appropriately to reduce apneas and hypopneas and provides suitable levels of positive airway pressure compared to conventional ASV.
详细描述
Adaptive servoventilation (ASV) is a type of non-invasive ventilation which ameliorates central sleep and/or mixed apnea and periodic breathing. Previous studies in the field have shown that treatment of periodic breathing with ASV improves sleep quality and quality of life. In reducing central apneas, ASV reduces overall arousal index, and increases overall slow wave sleep and rapid eye movement (REM) sleep more than oxygen, continuous positive airway pressure or bi-level treatments. ASV can also more effectively reduce central apnea and overall apnea/hypopnea index (AHI) in patients on long-term opiates, and appears to effectively treat Complex Sleep Apnea Syndrome. It is more effective than other forms of non-invasive ventilation for patients with central and/or mixed apnea or periodic breathing, and is better tolerated.
This is a prospective, randomised, crossover, observational study. Subjects will spend one night on conventional ASV and one night on modified ASV with full in-lab polysomnography (PSG) during therapy on both nights.
Objective and subjective parameters will be recorded and analysed.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •21+ years old
- •Chronic ResMed ASV therapy patient
- •Current ASV therapy for at least 4 weeks
- •Able to understand fully the study information and participation requirements
- •Provide signed informed consent
排除标准
- •Acute cardiac decompensation
- •Acute myocardial infarction within last 3 months
- •Resuscitation within last 3 months
- •Stroke with swallowing disorders or persistent hemiparesis
- •Blood pressure test at end expiratory pressure (EEP) 10cmH2O not passed
- •Untreated restless legs syndrome
- •Alcohol or drug abuse
- •Known cancer
- •Pregnancy
- •Conditions that could interfere with patients participating in and completing the protocol and/or the investigator deems their enrolment unsuitable
研究组 & 干预措施
Modified ASV
Modified ASV Enhanced ASV algorithm which includes auto-adjusting expiratory pressure.
干预措施: Modified Adaptive Servoventilation Device (Device)
Conventional ASV
Conventional ASV This is the current (predicate) ASV algorithm.
干预措施: Conventional Adaptive Servoventilation device (Device)
结局指标
主要结局
Apnea/Hypopnea Index (AHI)
时间窗: One night
Physiological sleep signals including pulse oximetry (SpO2), respiratory effort and nasal flow, will be recorded, analysed and reported in the form of an index per hour of sleep. Apnea-Hypopnea Index is calculated counting all apneas (reduction of respiratory flow by \>90% for at least 10 seconds) plus all hypopneas (reduction of respiratory flow by \>30% for at least 10 seconds with a 4% SpO2 reduction) divided by hours of sleep.
次要结局
- Oxygen Desaturation Index (ODI)(One night)