ACTRN12618001407280招募中未知
Testing of Continuous Positive Airway Pressure (CPAP) masks on adult obstructive sleep apnea (OSA) patients to assess product usability and performance against benchmark products.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- ResMed Ltd
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •MA17082018 (2018-2023):
- •Patients willing to give written informed consent
- •Patients who can read and comprehend English
- •Patients who >/= 18 years of age
- •Patients being treated for OSA for >/= 6 months
- •Patients currently using a suitable mask system
- •Patients who can trial the masks for up to 7 nights each
- •SLP-23-04-02 (2023-2028):
- •Participants willing to give written informed consent
- •Participants who >/= 18 years of age
- •Participants being treated for OSA for >/= 3 months
- •Participants currently using a suitable mask system(s)
- •Participants who can trial the masks for up to 7 nights each
排除标准
- •MA17082018 (2018-2023):
- •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
- •Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable) (for masks with magnetic clips only)
- •SLP-23-04-02 (2023-2028):
- •Patients using Bilevel flow generators
- •Patients who are 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
- •Patients who or whose bed partner has implantable medical devices which may contraindicate against masks with magnetic clips (exclusion criteria for study masks with magnetic clips only)
- •Patients who are currently enrolled in other clinical studies
研究者
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