The Evaluation of a Full Face Mask Seal 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
- 38
- 试验地点
- 1
- 主要终点
- Trial Mask Seal Acceptability
研究概览
简要总结
The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F&P Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number of 40-45 OSA participants will be recruited for the trial by the investigation site
详细描述
This study will involve three visits to the investigation site. During visit one participants will be randomized to, fitted with and issued with the first trial mask seal for use in- home for 7 ±4 days.
The participants will then come in to return the mask seal and be fitted and issued with the second trial seal for use in home for 7±4 days.
Visit Three will involve the participants returning the second trial seal and providing feedback.
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
- Single (Participant)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (22+ years of age)
- •Able to give informed consent
- •Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
- •Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
- •Fluent in spoken and written English
- •Existing F&P full face mask user
排除标准
- •Inability to give informed consent
- •Participant intolerant to PAP
- •Anatomical or physiological conditions making PAP therapy inappropriate
- •Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
- •Pregnant or may think they are pregnant.
研究组 & 干预措施
Group A
Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.
干预措施: Toffee full face mask with 'Improved Seal' (Device)
Group A
Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.
干预措施: Toffee full face mask with 'Normal Seal' (Device)
Group B
Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.
干预措施: Toffee full face mask with 'Improved Seal' (Device)
Group B
Participants will be randomized to receive either the "Improved Seal" or "Normal Seal" Toffee full face mask for a total of 7 ± 4 days from visit 1. At visit 2 they will return the first mask and be switched to the remaining mask for a total of 7 ± 4 days from visit 2.
干预措施: Toffee full face mask with 'Normal Seal' (Device)
结局指标
主要结局
Trial Mask Seal Acceptability
时间窗: 14 ± 4 days in-home
Preference for trial mask determined from questionnaires at the end of the trial - Subjective
Trial Mask Seal Comfort
时间窗: 7 ± 4 days in-home
Overall seal comfort determined from questionnaires- Subjective
次要结局
- Trial Mask Seal Usability(1 hour day-time appointment)
- Trial Mask Seal Treatment Performance - Objective(7 ± 4 days in-home)
- Trial Mask Seal Treatment Performance- Subjective(7 ± 4 days in-home)