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

• Conditions: Down Syndrome; Obstructive Sleep Apnea; Child

• Registration Number: NCT04022460
• Lead Sponsor: Children's Hospital of Eastern Ontario

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-17
• Study Start: 2019-09-17
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05
• Primary Completion: 2022-12
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Parental screening assessment of presence/absence of OSA based on homemade video clip	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.

Secondary Outcome Measures

Name	Time	Method
Physician assessment of severity of OSA based on homemade video clip	1 day	Questionnaire developed at CHEO by Pediatric Respirologists and Otolaryngologists. The question of interest is "Do you believe the severity of the obstructive sleep apnea is: a) Mild, b) Moderate, or c) Severe ?" This question will only appear to physicians who choose 'Yes' for Outcome #3. The reviewer will answer the question after reviewing the homemade video clips. This is an ordinal outcome with 'Mild' being considered the lowest score (1), and 'Severe' being considered the highest score (3). The gold standard reference test will be a polysomnography.
Parental assessment of severity of OSA based on homemade video clip	1 day	Questionnaire developed at CHEO by Pediatric Respirologists and Otolaryngologists. The question of interest is "Do you believe the severity of the obstructive sleep apnea is: a) Mild, b) Moderate, or c) Severe ?" This question will only appear to parents who chose 'Yes' for the primary outcome. The reviewer will answer the question after reviewing the homemade video clips. This is an ordinal outcome with 'Mild' being considered the lowest score (1), and 'Severe' being considered the highest score (3). The gold standard reference test will be a polysomnography.
Physician screening assessment of presence/absence of OSA based on homemade video clip	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?" Two physicians will independently 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.

Trial Locations

Locations (1)

Children's Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada