A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
California
-
Roseville、California、美国、95661
- California Sleep Solutions
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：F&P Toffee mask
Participants will be placed on this arm for a total of 14 ± 5 days from Visit two.
Participants will be using the trial full-face mask during this treatment arm.
|
Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Trial Mask Comfort
大体时间：14 ± 5 days In-Home
|
Comfort comparison of trial mask compared to their usual mask.
Determined from custom questionnaires - Subjective
|
14 ± 5 days In-Home
|
|
Trial Mask Performance - Objective
大体时间：14 ± 5 days In-Home
|
Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective
|
14 ± 5 days In-Home
|
|
Trial Mask Performance - Subjective
大体时间：14 ± 5 days In-Home
|
Seal leak in comparison to their usual mask.
Determine from questionnaires - Subjective
|
14 ± 5 days In-Home
|
|
Trial Mask Usability
大体时间：During Visit Two - 20 minutes
|
Whether the patient got the correct orientation and positioning of mask without help.
Usability interview - Subjective
|
During Visit Two - 20 minutes
|
|
Trial Mask Ease-of-Use
大体时间：14 ± 5 days In-Home
|
Usability of trial mask compared to usual mask.
Determined from questionnaires - Subjective
|
14 ± 5 days In-Home
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mask Leak Data
大体时间：14 ± 5 days In-Home
|
Leak data recorded from PAP device - Objective
|
14 ± 5 days In-Home
|
|
Seal Size Determination
大体时间：1 day-time appointment (1 hour) during Visit Two
|
Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant.
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1 day-time appointment (1 hour) during Visit Two
|
|
Efficacy Data
大体时间：14 ± 5 days In-Home
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AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective
|
14 ± 5 days In-Home
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- CIA-225
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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