Comparison of a Demand Oxygen Delivery to Continuous Flow for Administration of Oxygen During Sleep
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Drop in Apnea Hypopnea Index (0-4 /night) by 50 % or < 5 /hour
研究概览
简要总结
Conducting a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea.
The aim of the study is to conduct a comparison between the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los Angeles. 2 polysomnographies will be performed, one with continuous flow and the second with pulse flow.
详细描述
Cincinnati Children's Hospital received NIH funding to conduct a randomized control trial of oxygen in children with Down syndrome to treat moderate to severe obstructive sleep apnea. Oxygen may be delivered through continuous flow for the duration of the respiratory cycle or pulse flow during inspiration only. Pulse flow oxygen concentrators have been used clinically in adults. However, there is limited experience with this technology in children. The advantages of pulse flow oxygen concentrator are its portability and its ability in providing compliance data.
This is a pilot research study to compare the 2 methods of oxygen delivery during sleep in 15 children from Cincinnati Children's Hospital and Children's Hospital of Los Angeles. 2 polysomnographies will be performed, one with continuous flow and the second with pulse flow. The pilot study is conducted in preparation for a larger project which will include 7 sites aiming at determining the effect of oxygen treatment on the frequency of obstructive apnea, neurocognitive and cardiac outcomes. A separate Institutional Review Board (IRB) protocol of the larger study will be submitted later once approved by the NIH Data and Safety Monitoring Board.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 5-17 years with or without Down Syndrome (DS).
- •Children with obstructive sleep apnea (OSA) and obstructive apnea hypopnea index (OAHI) 5-40 / hour: The rationale for selecting this range of OAHI is that a large number of children with DS with this range of OSA severity are untreated for months to years. It is important to understand the response to oxygen across the spectrum of disease severity. Notably, children with severe disease are left with few options (e.g., tracheostomy).
- •Absence of clinically significant hypoxia defined as oxygen saturation < 88% for 5 minutes or episodic desaturation to 60% as these levels would otherwise identify children eligible to routinely receive oxygen.
排除标准
- •Current CPAP use with documented compliance (> 4 hrs/ night; > 70% of nights).
- •Oxygen saturation < 90% at rest during wakefulness
- •Chronic daytime or nighttime use of supplemental oxygen.
- •Unable to participate in a Polysomnogram (PSG).
- •Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound results in this trial.
结局指标
主要结局
Drop in Apnea Hypopnea Index (0-4 /night) by 50 % or < 5 /hour
时间窗: 6 months
Percent of children with a drop in Apnea Hypopnea Index (AHI) by 50% or \< 5 /hour
次要结局
- Value of Oxygen Saturation (SpO2)(6 months)
- Percentage of Oxygen Saturation (SpO2) and number of times it goes below 90%(6 months)
- Pulse Rate during sleep(6 months)
- Frequency of apnea happening during sleep(6 months)
- Total hours of Sleep Time(6 months)