Long Term Vent Flow Study of Prototype Nasal CPAP Mask System
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- ResMed
- 主要终点
- Changes in vent flow of the mask system, which will be recorded on a flow testing rig (units= LPM). Baseline flow in LPM will be compared to that at the conclusion of the trial.
研究概览
简要总结
As continuous positive airway pressure is the treatment choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance of a new mask system with diffuse vent technology. This is done by characterizing the mask flow over time and compare the performance between patients who apply 2 different washing procedures to the mask. The study will also subjectively assess breathing comfort and performance of the mask system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Participants willing to give written informed consent
- •Participants who can read and comprehend English
- •Participants using APAP for >6 months
- •Participants who are willing to use the mask system for the 3 month duration of the trial.
- •Participants who are over 18 years of age
- •Participants who currently use a nasal mask system
排除标准
- •Participants not willing to give written informed consent
- •Participants who cannot read and comprehend English
- •Participants using an inappropriate mask system
- •Participants on a Bilevel or ASV therapy
- •Participants who are pregnant
- •Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer lung injury; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection
- •Participants or whose bed partner with implantable metallic implants in the head, neck and chest region affected by magmetic fields (Non-ferrous implants may be acceptable)
- •Participants that weight <30 kg
- •Participants who are unsuitable to participate in the study in the opinion of the researcher
结局指标
主要结局
Changes in vent flow of the mask system, which will be recorded on a flow testing rig (units= LPM). Baseline flow in LPM will be compared to that at the conclusion of the trial.
时间窗: 12 weeks
The mask system will be flow tested after use when returned by the participant at each scheduled visit. The flow of the mask system will be recorded as per the mask to flow procedure of ISO17510 Sleep apnoea breathing therapy - Part 2: Annex B Exhaust flow test procedure. The results will be reported as an average flow in LPM. Results will be presented graphically with average flow on the vertical axis and use time (weeks) on the horizontal axis. This will allow us to assess any changes in vent flow over time.
次要结局
- Parameters such as the apnoea/hypopnoea index (AHI) will be recorded and analysed(12 weeks)
- Questionnaire to assess the perceived overall performance of the mask by the participant. Questions around comfort will be asked.(12 weeks)
- Bioburden quantification by laboratory testing of venting components at end of trial(12 weeks)