Assessment of the Performance of the Salt Lake Mask System as a Patient Interface in the Provision of Positive Airway Pressure (PAP) Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Subjectively Assessed Levels of Seal, Comfort, Stability and Overall Performance.
研究概览
简要总结
Assessment of the performance of the Salt Lake mask system acting as a patient interface in the provision of PAP therapy. This study will assess the suitability of this mask system in its current form for use.
详细描述
Sleep-disordered breathing (SDB) is a significant direct cause of morbidity and mortality, as well as being a significant indirect cause of morbidity and mortality impacting greatly upon health and quality of life when left untreated. Positive Airway Pressure (PAP) therapy is an effective and proven form of medical treatment for many types of SDB.
In order for PAP therapy to be effective, patient interfaces(masks) need to be both effective in their delivery of this treatment and accepted by prospective and current patients for use. This study will investigate the ability of the Salt Lake mask system to act effectively as a patient interface in PAP therapy, and its ability to be accepted by patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patients willing to give written informed consent
- •Patients who can read and comprehend English
- •Patients using the Swift FX mask system
- •Patients who can trial the mask for 7 nights
- •Patients who have used PAP therapy for a minimum of 6 months.
排除标准
- •Patients not willing to give written informed consent
- •Patients who can not read and comprehend English
- •Patients using an inappropriate mask system
- •Patients using Bilevel flow generators
- •Patients who are pregnant
- •Patients who are unable to comply with the protocol
- •Patients who have used PAP therapy for less than 6 months.
结局指标
主要结局
Subjectively Assessed Levels of Seal, Comfort, Stability and Overall Performance.
时间窗: 1 week
Participants in the study will complete a subjective assessment of the levels of seal, comfort, stability and overall Performance of Salt Lake Mask System in use.
次要结局
- Subjective Assessments of Ease and Intuitiveness in Assembly and Disassembly(1 week)
- Subjectively Assessed Levels of Skin Markings(1 week)