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Active Not RecruitingNCT04022460

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
141 (estimated)
Sponsor
Children's Hospital of Eastern Ontario · Academic / Other
Sex
All
Age
2 Years – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTVideo clip assessmentParents will take short video clips of their child sleeping at night. They will be asked to review the video clips and rate whether they think their child has obstructive sleep apnea (OSA), and if so, how severe it is. Two clinicians will review the video clips on a separate night.
DIAGNOSTIC_TESTPolysomnography (sleep study)Children will undergo a polysomnography as the gold standard test to assess for OSA.
OTHEREducational webinarAfter evaluating the video clips of their child sleeping, parents will watch an educational webinar on OSA in children with Down syndrome and how to recognize symptoms.

Timeline

Start date
2019-09-17
Primary completion
2026-09-01
Completion
2026-12-01
First posted
2019-07-17
Last updated
2026-03-18

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT04022460. Inclusion in this directory is not an endorsement.