Servo-Ventilation In-lab Polysomnography (PSG) Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Average Apnea Hypopnea Index Among Different Polysomnography Devices.
研究概览
简要总结
Continuous Positive Airway Pressure (CPAP) is the most effective treatment for the Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS). CPAP stabilizes the airway and prevents instability and collapse. With a stable and patent airway, breathing continues in a normal manner, gas exchange is improved, and there is no disruption of sleep related to disturbed breathing.
Auto Servo Ventilation (Auto SV) is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea. The main features of the Auto SV mode include:
- Normalization of ventilation by automatically adjusting Inspiratory Positive Airway Pressure (IPAP) pressure to achieve a target ventilation. IPAP is increased or decreased to help stabilize the ventilation.
- Provision of timed, back-up breaths during central apneas. The optimal back-up rate is automatically determined by the device based on the patient's breathing.
- Automatic control of Expiratory Positive Airway Pressure (EPAP) to treat obstructive events.
Several manufacturers produce these types of devices. The algorithms used to determine the IPAP, EPAP and minimum respiratory rate are different. The largest number of these devices currently in use are the BiPAP AutoSV Advanced System One (Philips Respironics, Murrysville PA) and the Variable positive airway pressure (VPAP) Adapt (ResMed Corp., San Diego CA).
详细描述
This study is to better understand the performance and features of the BiPAP autoSV Advanced System One. Philips Respironics will evaluate the PolySomnoGraphy (PSG) and Encore data from each night. The aim of the study is to characterize the acute outcomes of treatment provided by the device and evaluate any modifications made to the Philips Respironics device's algorithm
The participants for this study will be experienced in having used servo ventilation therapy at their home because it is only such patients who are already using servo ventilation as part of routine clinical care that are eligible for participation.
Participants will receive four (4) randomized PSG's during which they will receive treatment from the following devices in a randomized manner:
- FDA released Philips BiPAP AutoSV Advanced System One
- A Modified Philips BiPAP ASV
- FDA released ResMed S7 VPAP Adapt
- FDA released ResMed S9 VPAP Adapt
The participants sought for this effort will be previously prescribed a servo-ventilation device as part of routine clinical care.
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
- •Ability to provide consent
- •Currently prescribed servo ventilation therapy at home
- •At least two weeks of recent adherence and efficacy data from PAP device demonstrating adequate use of therapy (at least 4 hours of use per night and use on at least 9 of 14 nights)
- •Current device compliance report demonstrating residual Apnea-Hypopnea Index (AHI) of 5 or more
排除标准
- •Participants who are acutely ill, medically complicated or who are medically unstable
- •Participants in whom PAP therapy is otherwise medically contraindicated
- •Participants who are claustrophobic
- •Symptomatic ("Symptomatic" defined as hospitalized for heart failure or a change in cardiac medications, within the last two months) chronic heart failure (NYHA 2-4) and reduced LVEF≤45%, AND moderate to severe predominant central sleep apnea
- •Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 55mmHg).
- •Participants requiring any kind of oxygen therapy
- •Participants who have had surgery of the upper airway, nose, sinus, eyes, or middle ear within the previous 90 days
- •Participants with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLMI > 10).
研究组 & 干预措施
Philips BiPAP AutoSV Advanced System One
The Bi-Level Positive Airway Pressure system will be used and will be configured with these settings.
P max: 30 EPAP min: 4 EPAPmax: 15 Pressure Support (PS) min: 0 Pressure Support (PS) max: 15 BiFlex: 2 Rate: Auto
干预措施: Philips BiPAP AutoSV Advanced System One (Device)
Modified Philips BiPAP ASV
The modified Philips BiPAP ASV will be configured with these settings P max: 30 EPAP min: 4 EPAPmax: 15 PS min: 0 PS max: 15 BiFlex: 2 Rate: Auto
干预措施: Modified Philips BiPAP ASV (Device)
ResMed S7 VPAP Adapt
This is an FDA approved device and the following settings will be administered:
End-expiratory Pressure (EEP): 4 PSmin: 3 PSMax: 16
干预措施: ResMed S7 VPAP Adapt (Device)
ResMed S9 VPAP Adapt
This is an FDA approved device and the following settings will be administered:
EPAP min: 4 EPAPmax: 15 PS min: 0 PS max: 20 Max Ramp: Off
干预措施: ResMed S9 VPAP Adapt (Device)
结局指标
主要结局
Average Apnea Hypopnea Index Among Different Polysomnography Devices.
时间窗: 4 nights
The Apnea Hypopnea Index is the number of the apneas and hypopneas during one hour of sleep. The average of these events over one night were compared during each overnight device use.
次要结局
未报告次要终点