Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Trial Mask Comfort
研究概览
简要总结
The 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 participants who currently use a full-face mask will be recruited.
The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask by a sleep technician for use in-home (Visit 2). The participant then will come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trial full-face mask they will be asked if they would like to continue using the trial mask for a further six months in home. There will be a follow up phone call gain feedback or address any issues at months 2 and 4 of the six month extension period. At the end of the six month extension period, the participants will return the trial full-face mask to NTLSC and answer a few questions around their feedback on the mask after using it for six months.
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.
Data from initial 2 week trial is reported here.
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 diagnostic PSG night
- •Aged 22 and over (FDA defined as adult)
- •Either prescribed APAP, CPAP or Bi-Level PAP for OSA
- •Existing full-face mask users
- •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
Trial Mask Comfort
时间窗: 14 ± 5 days in-home
Determined from questionnaire - Subjective Uses a 5 point Likert Scale (Very Uncomfortable, Uncomfortable, Same as usual, Comfortable, Very Comfortable).
Participant Count of Acceptable Trial Mask Performance - Objective
时间窗: 14 ± 5 days in-home
Determined from AHI data, a measure of disease severity, recorded from the PAP device - Objective
Trial Mask Seal Performance - Subjective
时间窗: 14 ± 5 days in-home
Determined from questionnaire - Subjective Uses a 5 point Likert Scale
Trial Mask Ease of Cleaning
时间窗: 14 ± 5 days in-home
Determined from questionnaires - Subjective A single question asked participants to report their ability to clean the mask on a 5 point Likert Scale with scores ranging from very easy, easy, neutral, hard, and very hard.
Trial Mask Ease-of-use
时间窗: 14 ± 5 days in-home
Participants experience removing mask from face, determined from questionnaires and a sleep diary - Subjective Uses a 5 point Likert Scale. Also includes, discussion questions around comfort.
次要结局
- Participant Count of Acceptable Mask Leak(14 ± 5 days in-home)
- Participant Count of Seal Size Determination(1 day-time appointment (1 hour) Visit 2)