The Evaluation of a Novel Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F&P trial nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants.
详细描述
Visit 1 will involve the participants consented in to the trial. Participants will be fitted with the F&P trial nasal pillows mask for use in-lab.
The participant will then return the mask and have a interview, this ensures the maximum time participants will be exposed to the trial mask in lab will be in 1 night.
The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all participants within 1 week of the beginning of the study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (18+ years of age)
- •Able to give consent
- •Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
- •Prescribed PAP for OSA
- •Existing nasal pillows mask user
排除标准
- •Inability to give consent
- •Patients who are in a coma or a decreased level of consciousness
- •Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
- •Commercial drivers who are investigated by New Zealand Transport Agency
- •Current diagnosis of carbon dioxide (CO2) retention
- •Pregnant or may think they are pregnant
研究组 & 干预措施
Trial Continuous Positive Airway Pressure (CPAP) mask
Trial nasal pillows CPAP mask
干预措施: Nasal Pillows CPAP mask (Device)
结局指标
主要结局
Acceptability
时间窗: 1 night
Subjective Questionnaire
Ease of use
时间窗: 1 night
Subjective Questionnaire
次要结局
- Objective Leak Data(1 night)