Comparison of the Efficacy and Subjective Comfort of a Modified AutoSet Device With an Existing AutoSet Device (VPAP Auto) in Treating Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Oxygen Desaturation Index
研究概览
简要总结
The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.
详细描述
Obstructive sleep apnea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed or auto adjusted positive pressure to the upper airway via a tube and mask. The modified device to be assessed in this study will act in a similar way to the existing device, VPAP Auto, but utilizes an improved algorithm which should maintain or enhance the effectiveness of the treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years
- •Patients who are on CPAP therapy in AUTOSET mode for no less than 6 months
- •Patients who are using ResMed masks
排除标准
- •Patients who are unable to provide written informed consent
- •Patients who are unable to comprehend written and spoken English
- •Patients who are using Bilevel PAP
- •Patients who are pregnant
- •Patients who are suffering any of the following:
- •Acute respiratory infection
- •Acute sinusitis, otitis media or perforated eardrum
- •Pneumothorax or pneumomediastinum
- •Recent history of severe epistaxis requiring medical attention
结局指标
主要结局
Oxygen Desaturation Index
时间窗: One Night On Each Arm, approximately 8 hours each night
Number of oxygen desaturations per hour of sleep
Apnoea-Hypopnoea Index (AHI)
时间窗: One Night On Each Arm, approximately 8 hours each night
The number of apneas and hypopnoeas per hour of sleep measured on Nexus Auto \& VPAP Auto 25
次要结局
- Comfort of Breathing(One Night On Each Arm, approximately 8 hours each night)
- Satisfaction of Treatment(One Night On Each Arm, approximately 8 hours each night)
- Refreshed Feel(One Night On Each Arm, approximately 8 hours each night)