Assessment of Circuit Rebreathing During Continuous Positive Airway Pressure (CPAP) Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change in flow-adjusted average inspired oxygen fraction (FiO₂) during wake.
研究概览
简要总结
The goal of this research is to better understand how different CPAP mask designs affect airflow and rebreathing of exhaled carbon dioxide (CO₂) during sleep in individuals with obstructive sleep apnea (OSA).
详细描述
To understand the existence and severity of circuit rebreathing during treatment with continuous positive airway pressure (CPAP) using different sizes of the exhaust ports in individuals with obstructive sleep apnea (OSA).
Flow-adjusted end-tidal oxygen (PetO2) and carbon dioxide (PetCO2) will be assessed to determine the magnitude of hypoxic load during both wakefulness and sleep. To systematically assess these conditions, the conditions were defined as follows:
- 5A: 35 L/s exhaust flow with 5 cmH₂O PAP
- 5B: 23 L/s exhaust flow with 5 cmH₂O PAP
- 5C: 18 L/s exhaust flow with 5 cmH₂O PAP
- 5D: 13 L/s exhaust flow with 5 cmH₂O PAP
- 5E: 8 L/s exhaust flow with 5 cmH₂O PAP
- 0P: 35 L/s exhaust flow with 0 cmH₂O PAP
- 10A: 35 L/s exhaust flow with 10 cmH₂O PAP
- 10B: 23 L/s exhaust flow with 10 cmH₂O PAP
- 10C: 18 L/s exhaust flow with 10 cmH₂O PAP
- 10D: 13 L/s exhaust flow with 10 cmH₂O PAP
- 10E: 8 L/s exhaust flow with 10 cmH₂O PAP Primary endpoint is to evaluate the effect of exhaust flow on flow-adjusted average inspired oxygen fraction (FiO₂) during (1) wakefulness and (2) sleep between 5B vs. 5D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
The exhaust flow and PAP level conditions will be blinded for the participant.
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe OSA (AHI>20)
- •Self-reported CPAP users or have previously used CPAP
- •Self-reported holding pressure of maximum 13 cmH2O (if known)
- •Age: 21-70
- •BMI: 18-40 kg/m2
排除标准
- •Self-reported severe mouth-breathing
- •Requirement for nocturnal supplemental oxygen or other ventilatory support
- •Severe cardiovascular or pulmonary disease
- •Any unstable or acute medical condition
- •Any additional sleep disorder, including insomnia, except for OSA.
研究组 & 干预措施
5 cmH2O with 18L/s
18 L/s exhaust flow with 5 cmH₂O PAP
干预措施: Continuous positive airway pressure (CPAP) (Device)
5 cmH2O with 23L/s
23 L/s exhaust flow with 5 cmH₂O PAP
干预措施: Mask exhaust port flow (Other)
5 cmH2O with 35L/s
35 L/s exhaust flow with 5 cmH₂O PAP
干预措施: Continuous positive airway pressure (CPAP) (Device)
5 cmH2O with 35L/s
35 L/s exhaust flow with 5 cmH₂O PAP
干预措施: Mask exhaust port flow (Other)
5 cmH2O with 23L/s
23 L/s exhaust flow with 5 cmH₂O PAP
干预措施: Continuous positive airway pressure (CPAP) (Device)
5 cmH2O with 18L/s
18 L/s exhaust flow with 5 cmH₂O PAP
干预措施: Mask exhaust port flow (Other)
5 cmH2O with 13L/s
13 L/s exhaust flow with 5 cmH₂O PAP
干预措施: Continuous positive airway pressure (CPAP) (Device)
5 cmH2O with 13L/s
13 L/s exhaust flow with 5 cmH₂O PAP
干预措施: Mask exhaust port flow (Other)
5 cmH2O with 8L/s
8 L/s exhaust flow with 5 cmH₂O PAP
干预措施: Continuous positive airway pressure (CPAP) (Device)
5 cmH2O with 8L/s
8 L/s exhaust flow with 5 cmH₂O PAP
干预措施: Mask exhaust port flow (Other)
0 cmH2O with 35L/s
35 L/s exhaust flow with 0 cmH₂O PAP
干预措施: Mask exhaust port flow (Other)
10 cmH2O with 35L/s
35 L/s exhaust flow with 10 cmH₂O PAP
干预措施: Continuous positive airway pressure (CPAP) (Device)
10 cmH2O with 35L/s
35 L/s exhaust flow with 10 cmH₂O PAP
干预措施: Mask exhaust port flow (Other)
10 cmH2O with 23L/s
23 L/s exhaust flow with 10 cmH₂O PAP
干预措施: Continuous positive airway pressure (CPAP) (Device)
10 cmH2O with 23L/s
23 L/s exhaust flow with 10 cmH₂O PAP
干预措施: Mask exhaust port flow (Other)
10 cmH2O with 18L/s
18 L/s exhaust flow with 10 cmH₂O PAP
干预措施: Continuous positive airway pressure (CPAP) (Device)
10 cmH2O with 18L/s
18 L/s exhaust flow with 10 cmH₂O PAP
干预措施: Mask exhaust port flow (Other)
10 cmH2O with 13L/s
13 L/s exhaust flow with 10 cmH₂O PAP
干预措施: Continuous positive airway pressure (CPAP) (Device)
10 cmH2O with 13L/s
13 L/s exhaust flow with 10 cmH₂O PAP
干预措施: Mask exhaust port flow (Other)
10 cmH2O with 8L/s
8 L/s exhaust flow with 10 cmH₂O PAP
干预措施: Continuous positive airway pressure (CPAP) (Device)
10 cmH2O with 8L/s
8 L/s exhaust flow with 10 cmH₂O PAP
干预措施: Mask exhaust port flow (Other)
结局指标
主要结局
Change in flow-adjusted average inspired oxygen fraction (FiO₂) during wake.
时间窗: through study completion, an average of 1 year
Difference in FiO2 between 23L/s vs 13L/s exhaust flow at 5 cmH2O PAP.
Change in flow-adjusted average inspired oxygen fraction (FiO₂) during sleep.
时间窗: through study completion, an average of 1 year
Difference in FiO2 between 23L/s vs 13L/s exhaust flow at 5 cmH2O PAP.
次要结局
- Impact on hypoxic burden during sleep.(through study completion, an average of 1 year)
研究者
Atqiya Aishah, Ph.D.
Postdoctoral Research Fellow
Brigham and Women's Hospital