Evaluation of Positive Airway Pressure (PAP) Feature to Improve Patient Adherence to Therapy
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
- Hours Used
研究概览
简要总结
The purpose of the study is to evaluate if using the Acclimate feature at the beginning of Positive Airway Pressure (PAP) therapy results in patients using their PAP therapy at least as long as they would standard therapy. Additionally, the Acclimate feature will be evaluated with regard to patient comfort, ease of acceptance of PAP therapy, leak events, and respiratory events.
详细描述
Acclimate has been designed as a comfort feature for patients starting PAP therapy. The feature allows acclimatization to the targeted positive airway pressure setting. Using the Acclimate feature, the pressure increases incrementally over a period of time. The feature can be only be used for a set period of time, afterwards which the device initiates the therapeutic session at the prescribed pressure.
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
- 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
- •Subjects ≥18 years of age.
- •Recent diagnosis of moderate to severe OSA where fixed PAP is clinically indicated.
- •Naïve to PAP therapy.
排除标准
- •Patients requiring supplemental oxygen.
- •Patients with a history of pneumothorax, pneumomediastinum, cavities or cysts in the lung.
- •Previous surgery to the brain, middle or inner ear, pituitary gland or sinuses.
- •Middle ear infection or perforated ear drum.
- •Ongoing sinus infection/sinusitis.
- •Clinically significant epistaxis.
- •Predominant central sleep apneas in the subject's PSG.
结局指标
主要结局
Hours Used
时间窗: 30 days
The number of hours that each group used the device will be compared between subjects using fixed pressure with the Acclimate mode and subjects using fixed pressure without the Acclimate mode.
次要结局
未报告次要终点