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

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.

Study Overview

• Status: Recruiting
• Conditions: Child; Obstructive Sleep Apnea; Down Syndrome
• Intervention / Treatment: Diagnostic test: Video clip assessment; Diagnostic test: Polysomnography (sleep study); Other: Educational webinar

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 Type: Observational
• Enrollment (Anticipated): 141

Contacts and Locations

• Study Contact: Name: Henrietta Blinder; Phone Number: 4026 613-737-7600; Email: hblinder@cheo.on.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H8L1
      • Recruiting
      • Children's Hospital of Eastern Ontario
      • Contact: Henrietta Blinder; Phone Number: 4026 6137377600; Email: hblinder@cheo.on.ca
      • Principal Investigator: Sherri L Katz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental screening assessment of presence/absence of OSA based on homemade video clip	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental assessment of severity of OSA based on homemade video clip	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.	1 day
Physician screening assessment of presence/absence of OSA based on homemade video clip	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.	1 day
Physician assessment of severity of OSA based on homemade video clip	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.	1 day

Collaborators and Investigators

• Sponsor: Children's Hospital of Eastern Ontario
• Collaborators: The Physicians' Services Incorporated Foundation

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; Pediatric; Polysomnography; Down syndrome; Mobile technology; Screening tool
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Signs and Symptoms, Respiratory; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea; Down Syndrome
• Other Study ID Numbers: 19/30X

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No