Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 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 autoSV3 and compare with data from Respironics, Inc's BiPAP S/T device, to confirm that the algorithms in the BiPAP autoSV3 device can safely and effectively treat participants experiencing Comp SAS no worse than the BiPAP S/T 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
Primary Hypothesis and end-point:
The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than when compared to the BiPAP S/T device with respect to:
- Apnea-Hypopnea Index (AHI)
Secondary Hypothesis and end-points:
The use of the BiPAP autoSV3 device in participants with Comp SAS will treat those participants no worse than the BiPAP S/T device, with respect to:
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
- •Ability to provide consent.
- •Documentation of medical stability by investigator.
- •Currently using BiPAP S/T (At least 4 weeks on therapy).
- •Participants who previously demonstrated Complex Sleep Apnea (CSA), with a central apnea index (CAI) ≥5 during Diagnosis study or on Positive Airway Pressure (PAP) titration.
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 unwilling to wear PAP.
- •Participants who are currently prescribed oxygen therapy.
- •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 Periodic Limb Movement (PLM) Arousal Index > 15).
- •Participants who are unwilling to participate in the study.
研究组 & 干预措施
Respironics BiPAP S/T
Control Arm using Respironics BiPAP S/T
干预措施: BiPAP S/T (Device)
Respironics BiPAP Auto SV3
Treatment arm using Respironics BiPAP Auto SV3
干预措施: BiPAP Auto SV3 (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.
次要结局
- Central Apnea Index(2 nights)
- Mixed Apnea Index(2 nights)
- Sleep Efficiency(2 nights)
- Arousal Index(2 nights)
- Stages N1,N2,N3 and REM (R) Sleep (% TST)(2 nights)
- Obstructive Apnea Index(2 nights)
- Hypopnea Index(2 nights)
- Sleep Onset Latency(2 nights)
- Apnea Hypopnea Index- REM(2 nights)
- Apnea Hypopnea Index Using Modified Hypopnea Rule.(2 nights)
- REM Onset Latency(2 nights)
- Wake After Sleep Onset(2 nights)
- Total Sleep Time(2 nights)
- Periodic Limb Movement Index(2 nights)
- Apnea Hypopnea Index(REM, NREM and TST) During Epochs for Which Leak is Determined to Exist Within Acceptable Limits.(2 nights)
- Stages N1,N2,N3 and REM (R) Sleep (in Minutes)(2 nights)
- Nocturnal Oxygenation Index(2 nights)