Randomized Controlled Trial to Compare Effectiveness of DreamPort-Eclipse to a Traditional Nasal Mask
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bleep, LLC
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- Apnea-Hypopnea Index (AHI)
研究概览
简要总结
The Randomized Controlled Trial of Bleep DreamPort-Eclipse Study is a two-arm, randomized, prospective, non-blinded study to assess the effectiveness of the novel CPAP human interface design to improve leak, AHI, and pressure compared to a traditional nasal mask.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Data collected will be deidentified upon collection - surveys and assessment forms will be labelled with a numerical identifier.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device
排除标准
- •Any medical or behavioral conditions that would compromise subject safety
- •Under the age of 18 years old
结局指标
主要结局
Apnea-Hypopnea Index (AHI)
时间窗: 60 days
AHI recorded from the software built-in algorithm. The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation.
Leak
时间窗: 60 days
Data were captured from the device in L/min at 60 days. Leak is how much flow in L exits the mask while the patient wears it each min. It is recorded through proprietary algorithm undisclosed to the public by the device
Apnea-Hypopnea Index (AHI)
时间窗: 60 days
AHI recorded from the software built-in algorithm. The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation.
Leak
时间窗: 60 days
Data were captured from the device in L/min at 60 days. Leak is how much flow in L exits the mask while the patient wears it each min. It is recorded through proprietary algorithm undisclosed to the public by the device
CPAP Device Pressure (P95)
时间窗: 60 days
Therapeutic positive pressure (in cmH2O) that the device administer for 95% of the night. It is recorded through proprietary algorithm undisclosed to the public by the device.
次要结局
- Participant Satisfaction With the Mask Choice(60 days)
- Percentage of Participants Who Could Tolerate the Mask Well (Mask Tolerability)(60 days)