The Evaluation of the Toffee 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
- 38
- 试验地点
- 2
- 主要终点
- Toffee Mask Usability
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 of the F&P Toffee nasal pillows mask amongst obstructive sleep apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Ohio Sleep Medical Institute (OSMI)
详细描述
Visit 1 will involve the participants being consented into the trial. Visit 2 will involve the participants being fitted with the F&P Toffee nasal pillows mask for use in-home.
The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the Toffee mask in home will be 14 ± 4 days from visit two.
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 patients 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
- 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 nasal pillows 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.
结局指标
主要结局
Toffee Mask Usability
时间窗: 14 ± 5 days in-Home
Questionnaire on usability during second visit - Subjective. Participants rated overall usability of the mask on a 5 point likert type scale ranging from very easy, easy, neither, difficult or very difficult.
Toffee Mask Comfort
时间窗: 14 ± 5 days in-Home
Determine from questionnaires - Subjective Participants rated overall comfort of the mask by indicating on a 5 point likert type scale the degree of comfort they felt. Answer responses ranges from very good, good, neither, poor, or very poor
Toffee Mask Treatment Performance - Subjective
时间窗: 14 ± 5 days in-Home
Determined from questionnaires - Subjective Participants rated overall performance of the mask on a 5 point likert type scale with responses including very good, good, neither, poor, or very poor
Trial Mask Acceptability
时间窗: 14 ± 5 days in-Home
Participant count regarding whether they would continue using the trial mask if given the choice.
次要结局
- Toffee Mask Treatment Performance - Objective(14 ± 5 days in-Home)