Central Sleep Apnea Treated by CO2 Supplied by a Novel Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Oxygen Desaturation Index
研究概览
简要总结
In general, central sleep apnea is not as common as obstructive sleep apnea but it is common in patients with heart failure. It has been repeatedly shown that central sleep apnea worsens the prognosis of heart failure. The current concept in the development of CSA is hypocapnia which causes temporary cessation of respiratory neural output. Different methods for supplement of CO2 have been used to eliminate CSA. However, variation of CO2 concentration during overnight treatment and tight-fitting mask made the treatment uncomfortable. It is important to develop a device with a comfortable mask to supply constant low dose CO2 without breathing difficulty. We recently developed a device for treatment of CSA.
详细描述
Objective
To determine whether the device could improve sleep quality while eliminating CSA during the overnight study. Methods: Patients with central sleep apnea diagnosed by diaphragm EMG will be recruited in this study. CO2 concentration for treatment would be manually titrated during overnight PSG. Patients were then treated with an effective lowest concentration of CO2 derived from titration under PSG on the third night. The sleep apnea hypopnea index (AHI), central sleep apnea index (CHI), arousal index (ArI), Oxygen desaturation index (ODI), sleep structure, blood pressure, heart rate, diaphragm EMG, treatment side effects and treatment preference were to be observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to participate after informed consent
- •Males and females, any race and aged≥18yeras
- •Objectively confirmed central sleep apnea/Cheyne Stokes Respiration with an apnoea-hypopnoea- index (AHI)≥5/h by overnight polysomnography
排除标准
- •Obstructive sleep apnea
- •Severe COPD，FEV1/FVC<70% and FEV1<60%
- •Chronic CO2 retention with unknown reason
- •Severe nasal congestion
- •Poor understanding
结局指标
主要结局
Oxygen Desaturation Index
时间窗: One full night
Total number of oxygen desaturations≥3% /total sleep time(h)
Apnea Hypopnea Index
时间窗: One full night
Total number of apneas and hypopneas/total sleep time (h)
Central sleep apnea index
时间窗: One full night
Total number of central sleep apneas/total sleep time (h)
Arousal Index
时间窗: One full night
Total number of arousals/total sleep time(h)
Adverse effects
时间窗: One full night
Using questionnaire named side effects of feeling to assess adverse effects exiting or not, including dyspnea, noise, bloating, itchy face, dry mouth, ophthalmalgia, stuffy nose, et al. When the side effect events in intervening condition 2 times more than baseline is worse outcome.
Sleep structure
时间窗: One full night
Assessment of the sleep efficiency (percentage is calculated by dividing Total Sleep Time by Total Time in bed)
次要结局
未报告次要终点
研究者
Yuan-Ming Luo
Proffessor
State Key Laboratory of Respiratory Disease