NCT01199042已完成不适用
BiPAP (Automatic Servo Ventilation) autoSV Advanced in Central Apnea Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 6
- 主要终点
- Apnea/Hypopnea Index (AHI)
研究概览
简要总结
Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab polysomnography (PSG) and 3 months at home on patients with Central Sleep Apnea, Hunter Cheyne Stokes Respiration, or Complex Sleep Apnea.
详细描述
Participants who qualify will be scheduled for one full night, attended diagnostic PSG, one full night attended continuous positive airway pressure (CPAP) titration, and one full night attended BiPAP autoSV Advanced titration PSG. Participants will be provided a BiPAP autoSV Advanced to use at home for 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, ages 21-
- •Able and willing to provide written informed consent.
- •Diagnosis of Central Sleep Apnea such as Hunter Cheyne Stokes Breathing, Complex Sleep Apnea, or Central Apnea with current daily Opioid use or any other predominant central sleep apnea.
- •For participants diagnosed with Hunter Cheyne Stokes Breathing, at least 3 cycles of crescendo-decrescendo breathing amplitude AND either a Central Apnea Index (CAI) ≥ 5/hour OR the crescendo-decrescendo cycles last at least 10 consecutive minutes from an attended Diagnostic Polysomnogram (PSG).
- •For participants diagnosed with Central Sleep Apnea with current daily Opioid use or any other predominant central sleep apnea, an Apnea/Hypopnea Index (AHI) ≥ 15 and CAI > 5 from an attended Diagnostic PSG.
- •For participants diagnosed with Complex Sleep Apnea, an AHI ≥ 15 and CAI > 5 from a CPAP titration.
- •Systolic blood pressure > 80 mm Hg at Visit
- •Agreement to undergo a full-night, attended Diagnostic PSG.
- •Agreement to undergo a full-night, attended CPAP titration PSG.
- •Agreement to undergo a full-night, attended BiPAP automatic Servo Ventilation (autoSV) Advanced titration PSG
排除标准
- •Active participation in another interventional research study.
- •Diagnosis of acute decompensated heart failure.
- •Surgery of the upper airway, nose, sinus or middle ear within the last 90 days.
- •Major medical or psychiatric condition that would interfere with the demands of the study or the ability to complete the study. For example, severe unstable chronic lung disease, neuromuscular disease, cancer, or end stage renal failure.
- •Qualifying for or awaiting heart transplantation.
- •Currently prescribed oxygen therapy (e.g. as needed, nocturnal, or continuous).
- •At home treatment with adapted Servo Ventilation (ASV) or Bilevel Positive Airway Pressure (PAP) therapies.
- •Unable to use PAP therapies due to physical (e.g. facial structural abnormalities) or cognitive (e.g. dementia) issues.
- •Participants in whom PAP therapy is medically contraindicated.
- •Uncontrolled hypertension (systolic ≥ 200 mm Hg/diastolic ≥ 120 mm Hg).
- •Narcolepsy.
- •Untreated Restless Legs Syndrome.
- •Periodic Limb Movement arousal index > 20/hr.
结局指标
主要结局
Apnea/Hypopnea Index (AHI)
时间窗: During a single night of polysomnography lasting up to 8 hours.
To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights.
次要结局
- Epworth Sleepiness Scale(3 months)
- Average Therapy Pressure Values(3 months)
- Breathing Event Indexes(from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment)
研究者
研究点 (6)
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