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临床试验/NCT04022460
NCT04022460进行中(未招募)不适用

Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)

Children's Hospital of Eastern Ontario1 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2019年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
141
试验地点
1
主要终点
Parental screening assessment of presence/absence of OSA based on homemade video clip

研究概览

简要总结

This study aims to see if mobile video clips (smartphone recordings) can be used to screen children with Down syndrome to identify those at highest risk of obstructive sleep apnea (OSA), so they can be prioritized for an earlier sleep study. Parents will be asked to record short video clips of their child sleeping, and then rate whether they think their child has OSA. Later, children will undergo a sleep study to compare to the ratings.

详细描述

Children with Down syndrome have approximately a 50% chance of developing obstructive sleep apnea (OSA) in their lifetime. OSA is a serious condition where a person stops breathing periodically during sleep; it is associated with high blood pressure, behavioural issues, and lower quality of life. Early diagnosis and treatment is critical, but the best way to diagnose OSA, a 'sleep study', is in short supply. Given the limited resources, this study aims to see if mobile video clips (smartphone recordings) can be used to screen children with Down syndrome to identify those at highest risk of OSA, so they can be prioritized for an earlier sleep study.

Parents of children with Down syndrome, recruited from clinic, will be asked to record short video clips of their child sleeping. Parents will independently rate whether they think their child has OSA and how severe it is, based on the videos, as will two clinicians. Parents will also watch an educational webinar and be asked to re-rate the presence and severity of OSA in their child, to see if the webinar improves their accuracy. Finally, children will undergo a sleep study to compare to the ratings. This study will help determine whether videos can be used to accurately screen for OSA in this high risk population, prioritizing children for earlier diagnosis and treatment.

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

入选标准

  • Diagnosis of Down syndrome
  • Within the catchment area of the Children's Hospital of Eastern Ontario Down Syndrome clinic

排除标准

  • Previous diagnosis of sleep-disordered breathing on polysomnography
  • No access to mobile technology to record video clips
  • Children unable to cooperate for polysomnography
  • Caregiver does not speak French or English

结局指标

主要结局

Parental screening assessment of presence/absence of OSA based on homemade video clip

时间窗: 1 day

Questionnaire developed at CHEO by Pediatric Respirologists and Otolaryngologists. The question of interest is "Do you think your child has obstructive sleep apnea?" The reviewer (a parent) will choose 'Yes' or 'No' after reviewing the homemade video clips. This is a dichotomous outcome with 'Yes' considered as the highest score. The gold standard reference test will be a polysomnography.

次要结局

  • Physician assessment of severity of OSA based on homemade video clip(1 day)
  • Parental assessment of severity of OSA based on homemade video clip(1 day)
  • Physician screening assessment of presence/absence of OSA based on homemade video clip(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherri Katz

Chief, Division of Pediatric Respirology

Children's Hospital of Eastern Ontario

研究点 (1)

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