Assessment of the Performance of the Tasman CPAP System in Treating Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)
研究概览
简要总结
Assessment of the performance of the Tasman CPAP system in treating obstructive sleep apnea. The purpose of this study is to (1) evaluate the performance of this system in the efficacy of the treatment in comparison to S8 Escape, and (2) to evaluate the performance of the Tasman device via subjective assessment of comfort and ease of breathing compared to the participant's current CPAP device.
详细描述
Obstructive Sleep Apnoea (OSA) is a condition characterised by partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive airway pressure to the upper airway via a tube and mask. The mask is attached to the participant's nose via head straps. The type of mask used is dependent upon participant choice and comfort and the mask that provides the best fit.
Some participants stop using CPAP therapy finding it difficult to tolerate due to leak issues or discomfort from their nasal mask. Another frequent concern is mask dislodgment while sleeping causing leaks and consequently waking the patient up.
The purpose of this study is to evaluate the performance of the Tasman CPAP system via objective and subjective assessment of comfort and ease of breathing compared to the participant's current CPAP device.
Aim
- To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)
- To evaluate the performance of the Tasman CPAP system in terms of comfort of breathing and general ease of use
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（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 being treated for OSA for >6 months
- •Patients using a ResMed nasal mask system
- •Patients who can trial the trial mask for 7 nights
排除标准
- •Patients not willing to give written informed consent
- •Patients who can not read and comprehend English
- •Patients being treated for OSA for <6 months
- •Patients using an inappropriate mask system
- •Patients using Bilevel flow generators
- •Patients who are not using CPAP between 7 and 13 cmH2O
- •Patients who are pregnant
- •Patients who cannot trial the trial mask for 7 nights
- •Patients with a hearing impairment
研究组 & 干预措施
Tasman CPAP
干预措施: Tasman CPAP system (Device)
结局指标
主要结局
To determine if the efficacy of the treatment is clinically equivalent to or better than the predicate device (S8 Escape)
时间窗: 1 week
次要结局
- To assess the usability of the Tasman CPAP system(1 week)