Clinical Trial of a New Mask Vent, Designed to Reduce Noise of Mask Venting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- The apnoea/hypopnoea index (AHI) will be recorded and analysed.
研究概览
简要总结
As continuous positive airway pressure is the treatment of choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance and usability of the new mask vent. This is done by comparing the apnea-hypopnea index (AHI) of patients, who will apply 2 different washing procedures to the new mask, at the end of the study and their baseline data obtained at the beginning of the study.The study will also assess the breathing comfort as well as obtaining subjective data on the usability of the new mask vent 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
- •Subjects who are using ResMed mask
- •Subjects willing to provide written informed consent
- •Subjects who have been treated for OSA > 6 months
- •Subjects who can read and comprehend English
- •Subjects ≥ 18 years old
- •Subjects who are using a ResMed S8 or S9 device
排除标准
- •Patients who are pregnant
- •Patient on bi level treatment
- •Patients being treated for OSA < 6 months
- •Patients who have a pre-existing lung disease/condition that would predispose them to pneumothorax (for example: COPD; lung cancer, fibrosis of the lungs; recent (<2 years ago) case of pneumonia or lung infection; lung injury).
- •Patients who are deemed unsuitable by the researcher due to the following reasons:
- •They do not comprehend English
- •They are unable to provide written informed consent
- •They are physically unable to comply with the protocol
研究组 & 干预措施
Group A_ washing procedure 1
This group will apply washing technique 1.
干预措施: CPAP mask (Device)
Group B_washing procedure 2
This group will apply washing technique 2.
干预措施: CPAP mask (Device)
结局指标
主要结局
The apnoea/hypopnoea index (AHI) will be recorded and analysed.
时间窗: 12 weeks
Breathing disruption events per hour of sleep will be measured and analysed
次要结局
- The level of comfort patients experience while using the new mask vent(12 weeks)
- Patient's and bed partner's perceptions of the mask vent(12 weeks)