NCT01626989已完成不适用
Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- Apnea-Hypopnea Index (AHI)
研究概览
简要总结
Comparing two BiPAP autoSV devices in participants with complex sleep apnea and determining if the new device will treat those participants no worse than when compared to its predecessor device.
详细描述
The use of the BiPAP autoSV4 device in participants with Complex Sleep Apnea Syndrome will treat those participants no worse than when compared to its predecessor device, the BiPAP autoSV Advanced™, with respect to:
• Apnea-Hypopnea Index (AHI)
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
- •Age 21-80
- •Ability to provide consent
- •Documentation of medical stability by investigator
- •Subjects who currently have been on Positive Airway Pressure (PAP) therapy for ≥ 4 weeks and who previously had a Continuous Positive Airway Pressure (CPAP) titration with CAI ≥
- •OR Subjects who currently have been on PAP therapy for ≥ 4 weeks and who had a diagnostic study done, with a CAI ≥ 5, and were prescribed PAP therapy without a CPAP titration.
- •Agreement to undergo a full-night, in-lab research CPAP Titration
- •Agreement to undergo two full-night, in-lab therapy research Polysomnography (PSG) on BiPAP autoSV devices
排除标准
- •Major medical or psychiatric condition that would interfere with the demands of the study, adherence to positive airway pressure, or the ability to complete the study. For example, unstable congestive heart failure, chronic lung disease, neuromuscular disease, daytime hypercapnia, cancer, or renal failure.
- •Systolic blood pressure < 80 mm Hg at Baseline Visit.
- •Participants in whom PAP therapy is otherwise medically contraindicated.
- •Participants who are unwilling to wear CPAP
- •Currently prescribed oxygen therapy (as needed, nocturnal, or continuous
- •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)/ Complex Sleep Apnea (CSA) sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLM Arousal Index > 15).
研究组 & 干预措施
BiPAP auto SV Advanced
Active Comparator
BiPAP auto SV Advanced
干预措施: BiPAP auto Advanced (Device)
BiPAP auto SV 4
Experimental
Auto Servo Ventilation Device
干预措施: BiPAP auto SV4 (Device)
结局指标
主要结局
Apnea-Hypopnea Index (AHI)
时间窗: Baseline, and 2 nights (1 night for each intervention)
Apnea-Hypopnea Index (AHI) is the number of apneas and hypopneas per hour of sleep.
次要结局
- Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices(Baseline, and 2 nights (1 night for each intervention))
- Obstructive Apnea Index (OAI)(Baseline, and 2 nights (1 night for each intervention))
- REM Onset Latency (ROL)(Baseline, and 2 nights (1 night for each intervention))
- Wake After Sleep Onset (WASO)(Baseline, and 2 nights (1 night for each intervention))
- Sleep Onset Latency (SOL)(Baseline, and 2 nights (1 night for each intervention))
- Sleep Efficiency (SE %)(Baseline, and 2 nights (1 night for each intervention))
- Hypopnea Index (HI)(Baseline, and 2 nights (1 night for each intervention))
- Central Apnea Index(CAI)(Baseline, and 2 nights (1 night for each intervention))
- Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep(Baseline, and 2 nights (1 night for each intervention))
- Arousal Index(Baseline, and 2 nights (1 night for each intervention))
- Mixed Apnea Index (MAI)(Baseline, and 2 nights (1 night for each intervention))
- Total Sleep Time (TST)(Baseline, and 2 nights (1 night for each intervention))
- Nocturnal Oxygenation(Baseline, and 2 nights (1 night for each intervention))
研究者
研究点 (6)
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