Comparison of Therapeutic Oxygen Versus Medical Air for the Treatment of Central Sleep Apnea in Infants and Children With Prader Willi Syndrome: A Proof of Concept Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Delta CAHI1
研究概览
简要总结
The aim of this study is to determine if treatment with Medical Air (21% oxygen in room air) compared to supplemental oxygen (100% oxygen) will lead to similar improvements in the central apnea-hypopnea index (CAHI) for infants with Prader-Willi Syndrome.
Despite the vast amount of research investigating the cause of central sleep apnea, there remain gaps in knowledge, lending to further research efforts. The decision to compare oxygen to medical air is based on several theorized mechanisms. The first of which is the supposition that provision of medical air may act as an arousal stimulus for the hypothalamus, thereby preventing sleep disordered breathing. Secondly, the hypercapnic challenge performed by Livingston et al demonstrated a delayed hypercapneic arousal response in PWS subjects despite simultaneous hyperoxia, leading us to question if therapeutic oxygen really plays a significant role in treating CSA. Lastly, the delivery of medical air via nasal prongs may provide sufficient arousal to terminate the cycle of events leading to central apnea, as described by Urquhart et al.
A deeper understanding of central sleep apnea is essential to ameliorating its adverse sequelae, which include symptoms of ADHD, impaired attention, behavioral problems, and academic difficulties.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The split-night polysomnograms (Arm A, Arm B) will be scored by a blinded independent sleep technologist. A Sleep Physician will report the sleep study and be blinded as to the gas assignment (ie Arm A or Arm B).
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants under age two with genetically confirmed Prader-Willi Syndrome
- •referred to HSC sleep clinic for evaluation with polysomnogram prior to initiation of growth hormone
- •infants found to have clinically significant central sleep apnea, defined as an apnea-hypopnea index (AHI) equal to or greater than 5
排除标准
- •infants delivered prematurely (less than 37 weeks gestational age)
- •term infants with a history of hypoxic-ischemic encephalopathy or stroke
- •any concurrent diagnoses that may cause sleep-disordered breathing (ie. craniofacial abnormalities, arnold-chiari malformation, etc)
- •infants with a need for daytime supplemental oxygen (ie. cardiac anomalies)
- •infants found to have low baseline oxygen saturations on PSG
研究组 & 干预措施
Arm A: Medical air followed by oxygen
干预措施: Medical Air vs Oxygen (Biological)
Arm B: Oxygen followed by medical air
干预措施: Medical Air vs Oxygen (Biological)
结局指标
主要结局
Delta CAHI1
时间窗: 2 years
Difference in CAHI at baseline compared to supplemental oxygen Delta CAHI1: CAHIoxygen - CAHIbaseline
Difference in CAHI1 and CAHI2
时间窗: 2 years
A comparison of change in CAHI1 and change in CAHI2 DeltaCAHI1: DeltaCAHI2
Delta CAHI2
时间窗: 2 years
Difference in CAHI at baseline compared to medical air Delta CAHI2: CAHImedical air - CAHIbaseline
次要结局
- Arousal Index1(2 years)
- Arousal Index2(2 years)
- Desaturation Index1(2 years)
- Desaturation Index2(2 years)
研究者
Reshma Amin
Respirologist, Clinician Investigator
The Hospital for Sick Children