Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Greater Than or Equal to 6 Hours of Sleep Data
研究概览
简要总结
The purpose of the study is: 1) To assess the feasibility of unmonitored polysomnography and 2) to compare apnea hypopnea index (AHI), average SPO2, and SPO2 nadir between unmonitored polysomnography and in-laboratory polysomnography in pediatric patients.
详细描述
The purpose of the study proposed is twofold. First Investigators will test the feasibility of conducting portable sleep monitoring in school aged children using the Clevemed Sleepview (www.clevelmed.com), one of the smallest portable sleep monitors commercially available at 57 grams. Second, Investigators will perform a direct comparison between the results obtained with this portable sleep monitor and those obtained from a standard-of-care in-laboratory attended sleep study performed at the St. Louis Children's Hospital Pediatric Sleep Center. These comparisons will be offered to the participants suspected of having sleep disordered breathing who present to the Washington University Pediatric Otolaryngology Department. Investigators will obtain the medical history and medications and results of the sleep study done at SLCH sleep lab from the medical record for research purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •5- to 12-years-old
- •Parental informed consent
- •Suspected Sleep Disordered Breathing
排除标准
- •Developmental delay
- •Use of home oxygen
- •History of Parasomnia (e.g. narcolepsy, restless leg syndrome, somnambulism)
- •History of tracheal surgery
- •History of tracheal stenosis
- •History of Nocturnal Hypoventilation
- •History of Central Sleep Apnea
- •Use of a Ventilatory Assist Device (e.g. Non-Invasive Positive Pressure Ventilation)
结局指标
主要结局
Greater Than or Equal to 6 Hours of Sleep Data
时间窗: greater than or equal to 6 hours
Feasibility of obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index using un-attended polysomnography; polysomnography analysis will be performed to determine if an apnea hypopnea index can be determined; \<5=Normal (no Sleep Apnea); 5-15=Mild Sleep Apnea; 15-30=Moderate Sleep Apnea; \>30 Severe Sleep Apnea
次要结局
- SPO2 Nadir(greater than or equal to 6 hours)
- SPO2 Result(greater than or equal to 6 hours)
- McGill Oximetry Score(greater than or equal to 6 hours)
- Apnea Hypopnea Index (AHI) Score(greater than or equal to 6 hours)