VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children (VIDEO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 625
- 试验地点
- 4
- 主要终点
- Diagnostic performance of video clips
研究概览
简要总结
Obstructive sleep apnea (OSA), which occurs in 1-4% of children, is a serious condition where a person stops breathing periodically during sleep because their airway closes. Untreated, it is associated with high blood pressure, behavioural problems, and lower quality of life. While early diagnosis and treatment are critical, there are significant barriers to access to a sleep study (the best diagnostic test). Questionnaires and overnight oxygen level recordings are limited in their ability to identify OSA. Better screening tools are needed to identify and prioritize children for sleep study testing. Short video clips, recorded using smartphones by parents, may be a useful tool to identify children at risk of OSA who would most benefit from a sleep study. The study aims to evaluate the ability of home smartphone video clips as a screening tool for moderate-severe OSA in children referred for a sleep study. The utility of video clips will also be compared to questionnaires and overnight oxygen saturation recordings. The investigators believe that the video clips will be able to predict moderate-severe OSA in children and that they will be better than standard clinical questionnaires or oxygen recordings. This multi-centre study will include 625 children referred for sleep studies for suspected OSA. Parents will be asked to record short video clips of their child sleeping, which will be rated for the presence and severity of OSA. Children will then undergo a sleep study, and parents will complete a questionnaire about sleep symptoms. Oxygen level recordings will be extracted from the sleep study. The diagnostic accuracy of video clips will be determined and compared to the questionnaire and oxygen level recording. This new approach to screening for pediatric OSA using widely available technology will allow children at the highest risk for moderate-severe OSA to be diagnosed and treated earlier, minimizing the risk of long-term complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2-18 years old
- •referred for diagnostic PSG to assess for OSA at their local tertiary care centre
- •parent/caregiver has access to mobile technology
排除标准
- •previous diagnosis of sleep-disordered breathing based on PSG in the last five years
- •unable to cooperate for PSG
- •clinician-suspected presence of central sleep apnea or central hypoventilation
- •genetic or congenital syndrome
- •non-verbal
- •use of PAP therapy or tracheostomy
- •parent/caregiver does not speak English or French
研究组 & 干预措施
Children with suspected Obstructive Sleep Apnea
Children referred for polysomnography (PSG) to investigate symptoms of obstructive sleep apnea (OSA).
干预措施: Parent-recorded smartphone video clips (Diagnostic Test)
结局指标
主要结局
Diagnostic performance of video clips
时间窗: From enrolment to end of data analysis (5 years).
Evaluate the diagnostic accuracy of video clips compared to PSG in the detection of moderate-severe OSA. Estimate the area under the ROC curve.
次要结局
- Specificity of video clips(From enrolment until the end of data analysis (5 years))
- The added benefit of the Pediatric Sleep Questionnaire (PSQ) and oximetry to the accuracy of video clips(From enrolment until the end of data analysis (5 years))
- Sensitivity of video clips(From enrolment until the end of data analysis (5 years))
- The added benefit of oximetry to the accuracy of video clips(From enrolment until the end of data analysis (5 years))
研究者
Sherri Katz
Division Chief of Pediatric Respirology and Senior Scientist
Children's Hospital of Eastern Ontario