An Investigation to Test a Prototype Full-face Mask in the Home Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Objective mask leak data measurement (System Leak)
研究概览
简要总结
This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial.
详细描述
This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial. The participants will be recruited from the Fisher and Paykel Healthcare Database of subjects with OSA (Ethics reference NTY/08/06/064), Auckland District Health Board (ADHB), or WellSleep Centre (Bowen Hospital, Wellington, NZ).
Participants will be on the trial for 21 days ± 6 days, using the prototypes at home for 14 days ± 3 days. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for 7 days ± 3 days prior to mask fitting with the Jupiter trial mask.
Fisher and Paykel Healthcare will act as the investigator and sponsor for this investigation. This study will be conducted in accordance with ICH/GCP Guidelines. No deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor (Bhavi Ogra) as soon as possible.
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
- •18+ years of age
- •Diagnosed with OSA by a practicing physician
- •Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP)). Patient can be naïve to CPAP therapy or experienced (6 months and more)
- •Existing full face mask users
- •Patients who are able to put on and remove their current mask without gross difficulty relating to an existing condition (e.g. arthritis of the hands).
排除标准
- •Inability to give informed consent
- •Anatomical or physiological conditions making PAP therapy inappropriate (e.g unconsolidated facial fracture)
- •Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
- •Current diagnosis of CO2 retention
- •Pregnant or think they may be pregnant
研究组 & 干预措施
Jupiter Full Face Mask
Participants to use full face mask in-home for a 14 ± 3 days in-home.
干预措施: Jupiter Full Face Mask (Device)
结局指标
主要结局
Objective mask leak data measurement (System Leak)
时间窗: Up to 21 ± 6 days in-home
Obtained from participant's CPAP device, measured in L/min
Subjective Measurement of leak assessed using a Subjective Questionnaire
时间窗: Up to 21 ± 6 days in-home
Subjective Questionnaire
Comfort assessed using a Subjective Questionnaire
时间窗: Up to 21 ± 6 days in-home
Subjective Questionnaire
Stability assessed using a Subjective Questionnaire
时间窗: Up to 21 ± 6 days in-home
Subjective Questionnaire
Noise assessed using a Subjective Questionnaire
时间窗: Up to 21 ± 6 days in-home
Subjective Questionnaire
Draft assessed using a Subjective Questionnaire
时间窗: Up to 21 ± 6 days in-home
Subjective Questionnaire
次要结局
- Preference of Mask assessed using a Subjective Questionnaire(Up to 21 ± 6 days in-home)
- Usability via mask unboxing/fitting exercise with a subjective questionnaire(Up to 21 ± 6 days in-home)