Breath Assist: A Continuous Positive Airway Pressure System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- reduction in AHI (Apnea Hypopnea Index) of the user, SpO2 will be improved during therapy
研究概览
简要总结
The mask will be evaluated for patient comfort and fit after subject selection based on the above criteria. The subject will enter weight and ramp speed. The mask delivers the desired pressure. The subject wears the suggested mask one night, then utilizes normal CPAP apparatus in the hospital the next night. The data is used to evaluate the mask’s efficiency. (Justification: The patient’s night sleep is not disturbed, and data from both devices on different night studies can assist in investigating and verifying the prototype)Both studies monitor SpO2 concurrently using a Beurer Pulse Oximeter. •Then, data is analyzed to determine mask efficacy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with AHI greater than 5 Subjects complaining of hypersomnia Mild and moderate sleep apnea subjects with increased carbon dioxide level.
排除标准
- •Severe or chronic respiratory ailment Subjects diagnosed with pneumothorax Subjects with Hypercapnia, Respiratory acidosis.
结局指标
主要结局
reduction in AHI (Apnea Hypopnea Index) of the user, SpO2 will be improved during therapy
时间窗: min 4 to 8 hours of single time usage during night sleep
次要结局
- improved sleep cycle, reduced ODI (oxygen desaturation index), SQI (sleep quality index) will be improved.(from 2 weeks of usage.)
研究者
Jayanthi T
SRM Institute of Science and Technology