Pilairo Q In-lab Market Research - Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Subjective Questionnaire of Mask Experience
研究概览
简要总结
Participants will undergo a normal sleep study. They will be randomised to use either a FPH Pilairo Q nasal pillow CPAP mask, or another mask. The sleep technician will record leak and pressure data, and complete questionnaires regarding satisfaction and ease of use at the end of the night. It is hypothesised that the Pilairo Q mask will be superior to other standard masks for CPAP therapy in terms of ease of use, satisfaction and overall titration experience.
详细描述
Participants will be recruited from patients who visit the sleep lab for CPAP titration. Only eligible participants, that provide written informed consent, will be enrolled into the investigation
Only those participants whom are previously diagnosed with an AHI >5 can be approached and enrolled into the study.
Once the consent form has been signed, participants will be randomly assigned to receive either Pilairo or any other standard care nasal/nasal pillows mask for their CPAP titration. A randomisation log will be provided by FPH.
The titration session will take place as per the lab's routine practice.
Throughout the night the Sleep Technician will record in the CRF the absolute leak value for the mask every 10 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •AHI equal or greater than 15 from the diagnostic night.
- •Equal or greater than 18 years of age
排除标准
- •Inability to give informed consent.
- •History of intolerance to CPAP.
- •Anatomical or physiological conditions making CPAP therapy appropriate (for example a deviated septum)
研究组 & 干预措施
FPH Pilairo Q CPAP mask
The Sleep Technician will fit the FPH Pilairo Q CPAP mask to the participant.
干预措施: FPH Pilairo Q CPAP mask (Device)
Any other market released nasal or nasal-pillow CPAP mask
The Sleep Technologist will fit the participant with any market released nasal or nasal-pillow CPAP mask
干预措施: Any other market released nasal or nasal-pillow CPAP mask (Device)
结局指标
主要结局
Subjective Questionnaire of Mask Experience
时间窗: 1 night in the lab
Sleep technicians reported on their experience using the mask after 1 night in the lab on a scale from 1 to 10 with a higher score indicating a better experience
次要结局
- Mask Leak(Every 10min, for up to 8 hours)
- Sleep Technicians Recommendation to Use Mask(1 night in the lab)