The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full-face Masks in the Treatment of OSA in Terms of Performance and Comfort
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
- 4
- 主要终点
- Seal Comfort
研究概览
简要总结
The investigation is a prospective non-blinded and semi-randomized clinical investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask.
详细描述
The investigation is a prospective non-blinded and semi-randomized investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask. A cohort of up to 38 pre-determined current nasal and full face mask users will be recruited by Fisher & Paykel Healthcare in Auckland New Zealand, Waikato DHB in Hamilton New Zealand, Hawkes Bay DHB in Hastings New Zealand and WellSleep Centre in Wellington New Zealand.
The study will involve baseline (visit one) gathering the participants' prescribed PAP therapy pressure and their usual mask (to have up-to-date records). The next visit (visit 2) 7 ± 4 days after visit 1, the participants will be fit the Prototype Full Face Mask (PFFM) mask or the alternative sizing based trial mask. At visit 3, which will be after 7 ± 4 days from visit 2, the participants will be crossed over to the mask. At visit 4, 7 ± 4 days after visit 3, all masks and devices will be collected from the participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis
- •Existing nasal or full face 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 APAP therapy inappropriate (e.g. unconsolidated facial structure)
- •Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
- •Current diagnosis of CO2 retention
- •Pregnant or may think they are pregnant.
研究组 & 干预措施
Alternative sizing model trial mask
In this arm participants who are randomized to the alternative sizing model based mask will be given the alternative sizing model based mask to use in home for the duration of this arm.
干预措施: Alternative sizing model based trial mask (Device)
Prototype Full Face Mask (PFFM)
In this arm, participants who are randomized to the PFFM will be given the PFFM to use in-home for the duration of this arm.
干预措施: Prototype Full Face Mask (Device)
结局指标
主要结局
Seal Comfort
时间窗: Up to 3 weeks in-home
Obtained from subjective questionnaire
Subjective Seal Leak
时间窗: Up to 3 weeks in-home
Obtained from subjective questionnaire
Objective Seal Leak
时间窗: Up to 3 weeks in-home
Measured by device data
次要结局
- Subjective correct mask selection(Up to 3 weeks in-home)
- Objective correct mask selection(Up to 3 weeks in-home)