A Development Study to Evaluate a Full-Face 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
- Trial Mask Comfort
研究概览
简要总结
This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
详细描述
This investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited.
This study will involve a baseline (Visit One) data gathering with the participant's positive airway pressure (PAP) therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask for use in-home (Visit Two).
The participant then will come in to return the mask (Visit Three) and give their feedback on their experience using the mask in home in the form of a structured interview during Visit Three. The maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from Visit Two.
The mask and CPAP (if used from the research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of their Obstructive Sleep Apnea.
Neither the investigators nor the participants will be blinded to 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
- •AHI ≥ 5 from the diagnostic night
- •Aged 22 and over (FDA defined as default)
- •Either prescribed APAP, CPAP or Bi-level PAP for OSA
- •Existing Full-Face mask user
- •Fluent in spoken and written English
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 CO2 retention
- •Pregnant or think they may be pregnant
结局指标
主要结局
Trial Mask Comfort
时间窗: 14 ± 5 days In-Home
Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective
Trial Mask Performance - Objective
时间窗: 14 ± 5 days In-Home
Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective
Trial Mask Performance - Subjective
时间窗: 14 ± 5 days In-Home
Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective
Trial Mask Usability
时间窗: During Visit Two - 20 minutes
Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective
Trial Mask Ease-of-Use
时间窗: 14 ± 5 days In-Home
Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective
次要结局
- Mask Leak Data(14 ± 5 days In-Home)
- Seal Size Determination(1 day-time appointment (1 hour) during Visit Two)
- Efficacy Data(14 ± 5 days In-Home)