Clinical trial NCT04022460: Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)
Official title: Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Down Syndrome
Obstructive Sleep Apnea
Child
Keywords: Polysomnography
Pediatric
Down syndrome
Obstructive sleep apnea
Screening tool
Mobile technology
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2019-07-17
Enrollment: 141
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of children with Down syndrome who have not previously been diagnosed with sleep-disordered breathing. We will approach children followed at the CHEO Down Syndrome clinic to participate in this study. All children within CHEO's catchment area will be considered eligible for this study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parental screening assessment of presence/absence of OSA based on homemade video clip
timeFrame: 1 day
Secondary outcomes:
measure: Parental assessment of severity of OSA based on homemade video clip
timeFrame: 1 day
measure: Physician screening assessment of presence/absence of OSA based on homemade video clip
timeFrame: 1 day
measure: Physician assessment of severity of OSA based on homemade video clip
timeFrame: 1 day
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
References: