Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 10
- 主要终点
- Apnea Hypopnea Index
研究概览
简要总结
This study is being undertaken to collect data from Respironics Inc's BiPAP Auto Servo Ventilation 3 (autoSV3) and compare with data from Respironics, Inc's BiPAP autoSV2, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Complex Sleep Apneas (Comp SAS) no worse than its predecessor, the BiPAP auto Servo ventilation 2 (autoSV2) device. This will be determined using a comparative, randomized design with the participants blinded to the therapy. Additionally, attempts will be made to blind the central scorer(s) with respect to which device is in use.
详细描述
This study was conducted to evaluate the therapeutic performance of a new auto Servo Ventilation device (Philips Respironics autoSV Advanced) for the treatment of complex central sleep apnea (CompSA). The features of autoSV Advanced include an automatic expiratory pressure (EPAP) adjustment, an advanced algorithm for distinguishing open versus obstructed airway apnea, a modified auto backup rate which is proportional to subject's baseline breathing rate, and a variable inspiratory support. Our primary aim was to compare the performance of the advanced servo-ventilator (BiPAP autoSV Advanced) with conventional servo-ventilator (BiPAP autoSV) in treating central sleep apnea (CSA).
Study Design: A prospective, multicenter, randomized, controlled trial.
Setting: Five sleep laboratories in the United States.
Participants: Thirty-seven participants were included.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pre-Study Inclusion Criteria:
- •Age 21-80
- •Ability to provide consent
- •Documentation of medical stability by investigator
- •Enrollment Inclusion Criteria:
- •Participants who, during the ambulatory polysomnography (PSG) study (Stardust), or in lab Diagnostic PSG demonstrated an Apnea Hypopnea Index (AHI) ≥10 or Central Apnea Index (CAI) ≥5
- •Participants who previously demonstrated Central sleep Apnea (CSA), with a CAI≥5 on Continuous Positive Airway Pressure (CPAP) titration.
排除标准
- •• Participants who are acutely ill, medically complicated or who are medically unstable.
- •Pregnancy (will confirm absence of pregnancy with a urine or serum pregnancy test in women of child bearing potential).
- •Participants in whom PAP therapy is otherwise medically contraindicated.
- •Participants who are unwilling to wear CPAP
- •Participants who are currently prescribed nocturnal oxygen use and are unable to forego oxygen during study nights.
- •Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have chronically elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 45mmHg).
- •Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
- •Participants with untreated, non- Obstructive Sleep Apnea (OSA)/CSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLM Arousal Index > 15).
- •Participants who are unwilling to participate in the study.
研究组 & 干预措施
Respironics BiPAP autoSV2, Then Respironics BiPAP autoSV3
Participants will be randomized to receive Respironics BiPAP autoSV2 first and Respironics BiPAP autoSV3 second.
干预措施: Respironics BiPAP autoSV2 (Device)
Respironics BiPAP autoSV2, Then Respironics BiPAP autoSV3
Participants will be randomized to receive Respironics BiPAP autoSV2 first and Respironics BiPAP autoSV3 second.
干预措施: Respironics BiPAP autoSV3 (Device)
Respironics BiPAP autoSV3, then Respironics BiPAP autoSV2
Participants will be randomized to receive Respironics BiPAP autoSV3 first and Respironics BiPAP autoSV2.
干预措施: Respironics BiPAP autoSV2 (Device)
Respironics BiPAP autoSV3, then Respironics BiPAP autoSV2
Participants will be randomized to receive Respironics BiPAP autoSV3 first and Respironics BiPAP autoSV2.
干预措施: Respironics BiPAP autoSV3 (Device)
结局指标
主要结局
Apnea Hypopnea Index
时间窗: 2 nights
The number of apneas and hypopneas per hour of sleep. Apneas are the cessation of airflow at the nostrils and mouth for at least 10 seconds as determined using nasal-oral thermistor or device flow. Hypopneas is shallow breathing in which the air flow in and out of the airway is significantly reduced as detected by nasal pressure or device flow - often associated with oxygen desaturation of 4% or EEG arousal. A central sleep scorer was utilized to review of the overnight PSGs and count the number of apneas and hyopneas per hour. The index is the average number for apneas+hyopneas per hour.
次要结局
- Obstructive Apnea Index(2 nights)
- Mixed Apnea Index(2 nights)
- Apnea Hypopnea Index (REM, NREM and TST) Using Modified Hypopnea Rule.(2 nights)
- Hypopnea Index(2 nights)
- Apnea Hypopnea Index- REM and NREM(2 nights)
- Central Apnea Index(2 nights)
- Rapid Eye Movement (REM) Onset Latency(2 nights)
- Wake After Sleep Onset(2 nights)
- Stages N1,N2,N3 (NREM), and REM (R) Sleep (in Minutes)REM, NREM and Total Sleep Time.(2 nights)
- Sleep Onset Latency(2 nights)
- Total Sleep Time(2 nights)
- Sleep Efficiency(2 nights)
- Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST)(2 nights)
- Arousal Index [Total, Apnea Hypopnea (AH)-Related, Periodic Limb Movement (PLM)-Related, 'Spontaneous'](2 nights)
- Nocturnal Oxygenation (Measured by Continuous Pulse Oximetry During Sleep Study)(2 nights)
- Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.(2 nights)