Assessment of the Seal, Comfort, Usability and Performance of the Prototype Whitsundays Nasal Mask System in the Singapore Home Environment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Subjective usability
研究概览
简要总结
Each Whitsunday mask or AirFit N30i Quiet mask is worn for 7 nights. The overall purpose of this study is to evaluate the performance of the Whitsundays nasal mask system (a prototype mask) compared to the ResMed AirFit N30i Quiet mask system (a benchmark mask) in relation to seal, comfort, usability, overall performance, and efficacy.
详细描述
This is a randomized, open label, cross over study to evaluate the Whitsundays nasal mask system (prototype mask) against a released mask system, the ResMed AirFit N30i Quiet mask system.
The Whitsundays nasal mask system will be compared with a released mask, ResMed's AirFit N30i Quiet, as it is also a nasal mask and the most appropriate benchmark. Study participants are experienced with CPAP masks and devices and therefore will use their experience to identify areas for potential improvement.
Recruitment will be done via phone calls/ SMS messages/ emails <TBC with PI>. Participants will be explained the details of the trial and those who wish to take part will be invited to a selected site for the first study visit.
Visit 1: Participants will provide written informed consent. Participants will be shown the mask systems and trial them for fit and comfort. Participants may be asked initial questions on their first thoughts on the mask systems. If the participant and assessor are happy to proceed, the participants will use the mask and loan CPAP for trial.
Visit 2: After trialing the mask systems, participants will be asked to complete a questionnaire regarding the seal and comfort of the mask system(s). Participants will then take the second mask system home to test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients willing to give written informed consent
- •Patients who can read and comprehend English
- •Patients who ≥ 21 years of age
- •Patients being treated for OSA with PAP therapy for ≥ 6 months
- •Patients currently using a suitable mask system (any nasal mask )
- •Patients who can trial the masks for up to 7 nights each
排除标准
- •Patients using Bilevel flow generators
- •Patients who are or may be pregnant
- •Patients with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
- •Patients believed to be unsuitable for inclusion by the researcher
研究组 & 干预措施
Whitsundays nasal mask
Participants will be asked to take home the investigational mask to use at night while they sleep in place of their own mask. The participant's therapy and comfort settings will not be altered.
干预措施: Positive Airway Pressure (PAP) Therapy (Device)
AirFit N30i Quiet mask
Participants will be asked to take home the comparator mask to use at night while they sleep in place of their own mask. The participant's therapy and comfort settings will not be altered.
干预措施: Positive Airway Pressure (PAP) Therapy (Device)
结局指标
主要结局
Subjective usability
时间窗: 6 weeks
Comparison of the seal, comfort, usability and overall preference of the Whitsundays nasal mask system to the AirFit N30i Quiet mask system and/or Criterion Score of 6
Apnea Hypopnea Index (Events/hour)
时间窗: 6 weeks
Objective AHI taken from the participant's CPAP device used during the trial, with a comparison of the Whitsundays nasal mask to the benchmark AirFit N30i Quiet mask or clinically relevant data. nasal mask system to the AirFit N30i Quiet mask system and/or Criterion Score of 6
次要结局
- Leak (L/minute)(6 weeks)
- Usage Hours (hours/night)(6 weeks)
- General Usability(6 weeks)
- CPAP Pressure (cmH2O)(6 weeks)