NCT02971436终止不适用
Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea
Fisher and Paykel Healthcare4 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2016年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Apnea Hypopnea Index (AHI)
研究概览
简要总结
This study will investigate the efficacy of the FPH modified positive airway pressure (PAP) device with or without SensAwake; and with different pressure support in OSA participants; in both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure delivery will also be evaluated. The FPH device will be compared to a market released product.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 and over
- •Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) - (Continuous Positive Airway Pressure (CPAP) or AutoCPAP). Participants can be naïve to CPAP or experienced users of CPAP.
- •For experienced users of PAP (CPAP or AutoCPAP): Using the PAP of more than 4 hours/night for 70% during the last 30 days (justification allowed by the investigator)
排除标准
- •Contraindicated for PAP (CPAP or AutoCPAP) therapy
- •Persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea)
- •Persons with obesity hypoventilation syndrome or congestive heart failure.
- •Persons that require supplemental oxygen with their PAP (CPAP or AutoCPAP) device
- •Persons with implanted electronic medical device (e.g cardiac pacemakers)
- •Persons who are pregnant or think they might be pregnant.
结局指标
主要结局
Apnea Hypopnea Index (AHI)
时间窗: 1 night
Through the polysomnography
次要结局
- Device Triggering(1 night)
- Therapy Comfort(3 nights)
- Compliance(3 nights)
研究者
研究点 (4)
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