Evaluation of the F&P Caramel Nasal Mask, US, 2023
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Therapeutic Efficacy
研究概览
简要总结
The purpose of this clinical investigation is to evaluate the performance and safety of the F&P Caramel nasal mask in a home environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons who are ≥22 years of age
- •Persons who weigh ≥66 pounds
- •Persons who have been prescribed PAP therapy by a physician
- •Persons who are existing nasal mask or sub-nasal mask users with ≥3 months of use prior to enrolment in the clinical trial
- •Persons who are compliant with PAP therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical trial
- •Persons who are fluent in spoken and written English
- •Persons who possess the capacity to provide informed consent
排除标准
- •Persons who are intolerant to PAP therapy
- •Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
- •Persons who are required to use PAP therapy for >12 hours per day or for extensive periods, not including sleep or naps
- •Persons who are trying to get pregnant, are pregnant, or think they may be pregnant
- •Persons who have an IPAP pressure of >30 cmH2O if on BPAP
- •Persons who use a PAP therapy device for the delivery of medicines, except supplemental oxygen
- •Persons who use a PAP therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the investigation site
结局指标
主要结局
Therapeutic Efficacy
时间窗: Baseline and14±5 days
Determined by Apnea-Hypopnea Index (AHI) recorded on PAP therapy machines after 14 days of use. The Apnea-Hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe AHI is measured by dividing the total number of recorded apneas (complete breathing stops) and hypopneas (shallow breathing episodes) by the total number of hours a person slept during an overnight sleep study or using a PAP device. Higher AHI values represent worse outcomes. There is no maximum theoretical index score.
Epworth Sleepiness Scale
时间窗: Baseline and14±5 days
All relevant time points used in the calculation in the Time Frame (e.g., baseline and 14±5 days). Note: change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 14±5 days minus value at baseline). Change between two time points is reported. Scale range: 0 (minimum score) to 24 (maximum score) (higher scores represent worse outcomes)
次要结局
未报告次要终点