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

NCT04022460 | Active Not Recruiting

• 1 other identifier: 19/30X
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome; Obstructive Sleep Apnea; Child

Keywords

Polysomnography; Pediatric; Down syndrome; Obstructive sleep apnea; Screening tool; Mobile technology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Physician assessment of severity of OSA based on homemade video clip

  1 day

Interventions

Video clip assessment DIAGNOSTIC_TEST

Parents 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.

Polysomnography (sleep study) DIAGNOSTIC_TEST

Children will undergo a polysomnography as the gold standard test to assess for OSA.

Educational webinar OTHER

After 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.

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H8L1, Canada

Location

MeSH Terms

Conditions

Down Syndrome; Sleep Apnea, Obstructive

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Pediatric Respirology

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: September 17, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

CA (1)