Investigative Headgear With Nasal Pillows CPAP Mask
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reliability of the headgear using a Questionnaire
研究概览
简要总结
This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.
详细描述
20 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level Positive airway pressure (PAP) for the treatment of their Obstructive Sleep Apnea (OSA). These include current CPAP mask users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •AHI≥5 from the diagnostic night
- •≥18 years of age
- •Prescribed CPAP or Bi-level therapy for OSA
- •Existing F&P Pilairo Q, Eson, Simplus mask users
排除标准
- •Inability to give informed consent
- •Patient intolerant to CPAP
- •Anatomical or physiological conditions making CPAP therapy inappropriate
- •History of respiratory disease or carbon dioxide (CO2) retention
- •Pregnant or think they may be pregnant
- •Investigated by Land Transport Safety Authority
研究组 & 干预措施
Headgear
Investigative Headgear with CPAP mask
干预措施: Investigative Headgear with CPAP mask (Device)
结局指标
主要结局
Reliability of the headgear using a Questionnaire
时间窗: Monthly over a period of 6 months
Assessment of headgear properties on a monthly basis via custom questionnaire via phone call
Durability of the headgear by testing
时间窗: Monthly over a period of 6 months
Assessment of headgear properties on a monthly basis, and changes to the headgear
次要结局
- Performance in regards to leak of the headgear(Monthly over a period of 6 months)
- Performance in regards to comfort of the headgear(Monthly over a period of 6 months)