Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea in New Zealand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire
研究概览
简要总结
Currently, Fisher and Paykel Healthcare (FPH) is developing a new nasal mask.
This investigation is designed to evaluate the performance of the trial nasal mask, focused specifically on how the different seal sizes will perform on Obstructive Sleep Apnea participants who are currently on Positive Airway Pressure therapy.
Participant's prescribed treatment pressure with their usual mask will be collected for 7 days ± 3 days prior to mask fitting with the trial nasal mask. They will then be issued with the trial nasal mask to use in-home for 14 days ± 4 days.
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
- •Diagnosed with Ostructive Sleep Apnea by a practicing physician or clinicans
- •Existing nasal or nasal pillows user
- •Prescribed Positive Airway Pressure therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))
排除标准
- •Inability to give informed consent
- •Pregnant or think they may be pregnant
- •Anatomical or physiological conditions making Positive Airway Pressure therapy inappropriate (e.g unconsolidated facial fracture)
- •Patients who are in a coma or decreased level of consciousness
- •Current diagnosis of CO2 retention
- •Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
研究组 & 干预措施
Trial Nasal Mask
The participant will use the Saturn nasal mask for 2 weeks in home
干预措施: Trial Nasal Mask (Device)
结局指标
主要结局
Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire
时间窗: 2 weeks in home
次要结局
- Preference of the Trial Nasal mask compared to the participant's usual mask through a custom questionnaire.(2 weeks in home)
- Seal performance of the trial Nasal mask as measured by the subjective perception of leak through a custom questionnaire, in addition to objective leak data and treatment efficacy through the Positive Airway Pressure therapy device.(2 weeks in home)
- Objective leak data through the Positive Airway Pressure therapy device(2 weeks in home)
- Treatment efficacy through the Positive Airway Pressure therapy device(2 weeks in home)