Personal Therapy Comfort Settings Pilot Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Comparison of treatment continuance between the control group and active treatment group.
研究概览
简要总结
350 participants will be enrolled in this study. The target population are patients newly diagnosed with OSA and starting CPAP treatment.
User accessible customizable comfort settings (Response setting, expiratory pressure relief (EPR) on/off and EPR level, and Ramp) will be set to either default (control group), or personalized for that participant (active treatment group).
Usage will be recorded for the first 1 month of CPAP treatment, to determine if customizing comfort settings can improve CPAP compliance
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
- Double (Participant, Care Provider)
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
- •Patients willing to give written informed consent
- •Patients who can read and comprehend English
- •Patients who are ≥ 18 years of age
- •Patients newly diagnosed with OSA and indicated for CPAP therapy.
排除标准
- •Patients who have previously used PAP therapy
- •Patients who require a bilevel device
- •Patients who are or may be pregnant
- •* Patients who are unable to attend follow up appointments
- •Patients with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury
- •Patients believed to be unsuitable for inclusion by the researcher
研究组 & 干预措施
Default comfort settings
Comfort settings will be set to default (out of the box setttings)
干预措施: continuous positive airway pressure (CPAP) (Device)
Personalized Therapy Comfort Settings
Comfort settings will be personalized to each user
干预措施: continuous positive airway pressure (CPAP) (Device)
结局指标
主要结局
Comparison of treatment continuance between the control group and active treatment group.
时间窗: 4 weeks after commencement of CPAP
Patients who drop off treatment (stop using CPAP treatment) in each group will be compared after 1.5 months of CPAP treatment.
次要结局
- Mask leak(4 weeks after commencement of CPAP)
- comparison of compliance between the control group and active treatment group(4 weeks after commencement of CPAP)
- Treatment efficacy(4 weeks after commencement of CPAP)
- Settings changes(4 weeks after commencement of CPAP)
- Ad hoc contacts(4 weeks after commencement of CPAP)