A Development Study to Evaluate a Nasal 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
- 37
- 试验地点
- 2
- 主要终点
- Number of Participants Subjective Performance Rating of the Nasal Mask
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
The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA patients who currently use a nasal or nasal pillows mask will be recruited
This study will involve a baseline (Visit One) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial nasal mask for use in-home (Visit Two). The participant then will come in to return the mask (Visit Three) and give 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 loan 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 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AHI ≥ 5 from diagnostic PSG night
- •Aged 22 and over (FDA defined as adult)
- •Either prescribed APAP, CPAP or Bi-Level PAP for OSA
- •Existing nasal or nasal pillows mask users (preferable 70%:30% split)
- •Fluent in spoken and written English
排除标准
- •Inability to give informed consent
- •Patient intolerant to CPAP therapy
- •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
Number of Participants Subjective Performance Rating of the Nasal Mask
时间窗: 14 ± 5 days In-Home
Performance reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Number of Participants Subjective Reporting of Nasal Mask Usability
时间窗: During Visit Two - 20 minutes
Usability reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Number of Participants Reporting Comfort Compared to Their Usual Mask.
时间窗: 14 ± 5 days In-Home
Comfort reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Number of Participants PAP Device Performance Reporting
时间窗: 14 ± 5 days In-Home
Determined from data recorded from the PAP device to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Number of Participants Subjective Recording of Ease of Nasal Mask Use.
时间窗: 14 ± 5 days In-Home
Ease of use reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
次要结局
- Number of Participants Leak Compared to Usual Mask(14 ± 5 days In-Home)
- Number of Participants With Correct Nasal Mask Size Determination(1 day-time appointment (1 hour))