Analysis of a New CPAP Mask for Patients With Sleep-disordered Breathing and Treated With Positive Airway Pressure (PAP) Thearapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- To measure and compare the prevalence of microorganisms within the new mask over a period of 8 weeks
研究概览
简要总结
BACKGROUND AND AIMS Continuous positive airway pressure (CPAP) is an effective therapy to treat sleep apnea. Sleep apnea is a condition where the airways collapse when the patient is asleep. CPAP treats sleep apnea by delivering an air pressure to the airways, splinting the airways open. CPAP is a device that sits besides the bed and is applied to the patient using a face mask.
The development of new CPAP masks is an on-going focus at ResMed Ltd in a bid to improve comfort and user compliance. ResMed are developing a new mask and investigations are required to evaluate mask performance over time.
ResMed Ltd design and manufacturer CPAP masks. The revision and development of masks is an on-going focus of the company in a bid to improve usability and patient compliance while maintaining optimum treatment. ResMed is developing a new mask. Investigations are therefore required to determine how much matter is built-up on the mask over time and to evaluate mask performance (including comfort and seal) and efficacy.
AIMS
The aims of the study are:
- To measure and compare the change in the abundance of microbes on the new mask over a period of 8 weeks
- To measure and compare the change in comfort, seal, stability, efficacy, leak and user compliance of this new mask over a period of 8 weeks
- To measure and compare the change in comfort, seal, stability, efficacy, leak and user compliance of this new mask versus an available mask
It is hypothesised that:
- The new mask acquires microbes from the user but there is no difference in the abundance of microorganisms between 2 and 8 weeks.
- The new mask maintains the same degree of comfort, seal, stability, efficacy, leak and compliance between 2 and 8 weeks.
- Compared to the existing mask, the new mask provides a higher degree of comfort, seal and stability and improves user compliance. The new mask also maintains efficacy, and maintains or reduces leak compared to the current masks.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 yrs old
- •Diagnosed with obstructive sleep apnoea
- •Been using CPAP therapy for at least 6 months
排除标准
- •Has a lung disease/condition
- •Using bilevel therapy
- •Is unable to participate for the duration of the study
结局指标
主要结局
To measure and compare the prevalence of microorganisms within the new mask over a period of 8 weeks
时间窗: up to 8 weeks of use
The mask is for single user use only. The participants will be instructed not to wash or clean the material for the duration of the study. The mask will be returned in a sealed bag and sent off for testing within 24 hrs after the trial.
次要结局
- Measure and compare mask efficacy over a period of 8 weeks(After 2, 4, 6 and 8 weeks of use)