Comparison of the Subjective and Objective Performance of a Novel Continuous Positive Airway Pressure (CPAP) System With a Traditional Continuous Positive Airway Pressure (CPAP) System.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Subjective usability ratings of the prototype system using a visual analogue scale, compared to a reference level and the second full system.
研究概览
简要总结
Randomised crossover trial of a novel and traditional Continuous Positive Airway Pressure (CPAP) system in Obstructive Sleep Apnoea patients.
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
- 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
- •Participant is willing to provide written informed consent
- •Participant is able to read and comprehend written and spoken English
- •Participant is ≥ 18 years of age
- •Participant has been diagnosed with Obstructive Sleep Apnoea (OSA)
- •Participants has been established on Continuous Positive Airway Pressure (CPAP) for ≥ 6 months
- •Participants is currently using the same mask type/variant as the interventional mask system to be evaluated
- •Participants is able to participate for the duration of the study
排除标准
- •Participant is not willing to provide written informed consent
- •Participant is unable to read and comprehend written and spoken English
- •Participant is < 18 years of age
- •Participant has not been diagnosed with Obstructive Sleep Apnoea (OSA)
- •Participant has not been established on Continuous Positive Airway Pressure (CPAP) for ≥ 6 months
- •Participant is not currently using the same mask type/variant as the interventional mask system to be evaluated
- •Participant is unable to participate for the duration of the study
- •Participant is pregnant
- •Participant is established on bi-level support therapy
- •Participant, or participants bed partner, has metallic implants in head neck or chest
- •Participant has a with a pre-existing lung disease or a condition that would predispose them to pneumothorax (e.g. Chronic Obstructive Pulmonary Disease (COPD), lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection, lung injury)
- •Participant is unsuitable to participate in the study in the opinion of the researcher
研究组 & 干预措施
Arm 1
Participants randomised to Arm 1 will receive an intervention of 7 nights with the Novel system followed by 7 nights with theTraditional system
干预措施: Novel System (Device)
Arm 1
Participants randomised to Arm 1 will receive an intervention of 7 nights with the Novel system followed by 7 nights with theTraditional system
干预措施: Traditional System (Device)
Arm 2
Participants randomised to Arm 1 will receive an intervention of 7 nights with the Traditional system followed by 7 nights with the Novel system
干预措施: Novel System (Device)
Arm 2
Participants randomised to Arm 1 will receive an intervention of 7 nights with the Traditional system followed by 7 nights with the Novel system
干预措施: Traditional System (Device)
结局指标
主要结局
Subjective usability ratings of the prototype system using a visual analogue scale, compared to a reference level and the second full system.
时间窗: 1 year
Participants will be asked to complete a short questionnaire at the end of each week to evaluate the general usability of the system. The questionnaire will include questions related to system use and comfort. The participants will answer the questions using an 11-point Likert scale.
次要结局
未报告次要终点