VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parent-recorded smartphone video clips.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea (OSA). Basic parameters: 2 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children (VIDEO)
Overview
Obstructive sleep apnea (OSA), which occurs in 1-4% of children, is a serious condition where a person stops breathing periodically during sleep because their airway closes. Untreated, it is associated with high blood pressure, behavioural problems, and lower quality of life. While early diagnosis and treatment are critical, there are significant barriers to access to a sleep study (the best diagnostic test). Questionnaires and overnight oxygen level recordings are limited in their ability to identify OSA. Better screening tools are needed to identify and prioritize children for sleep study testing. Short video clips, recorded using smartphones by parents, may be a useful tool to identify children at risk of OSA who would most benefit from a sleep study. The study aims to evaluate the ability of home smartphone video clips as a screening tool for moderate-severe OSA in children referred for a sleep study. The utility of video clips will also be compared to questionnaires and overnight oxygen saturation recordings. The investigators believe that the video clips will be able to predict moderate-severe OSA in children and that they will be better than standard clinical questionnaires or oxygen recordings. This multi-centre study will include 625 children referred for sleep studies for suspected OSA. Parents will be asked to record short video clips of their child sleeping, which will be rated for the presence and severity of OSA. Children will then undergo a sleep study, and parents will complete a questionnaire about sleep symptoms. Oxygen level recordings will be extracted from the sleep study. The diagnostic accuracy of video clips will be determined and compared to the questionnaire and oxygen level recording. This new approach to screening for pediatric OSA using widely available technology will allow children at the highest risk for moderate-severe OSA to be diagnosed and treated earlier, minimizing the risk of long-term complications.
Interventions
- Diagnostic test Parent-recorded smartphone video clips
Parents will record smartphone video clips of their child asleep, which will be scored by pediatric sleep physicians for presence of moderate-severe OSA. Children will then undergo clinically indicated polysomnography (PSG). Video clips will be evaluated for diagnostic accuracy, with PSG as the gold standard.
Primary outcome measures
- Diagnostic performance of video clips [Time frame: From enrolment to end of data analysis (5 years).]
Secondary outcome measures (4)
- Specificity of video clips [Time frame: From enrolment until the end of data analysis (5 years)]
- Sensitivity of video clips [Time frame: From enrolment until the end of data analysis (5 years)]
- The added benefit of oximetry to the accuracy of video clips [Time frame: From enrolment until the end of data analysis (5 years)]
- The added benefit of the Pediatric Sleep Questionnaire (PSQ) and oximetry to the accuracy of video clips [Time frame: From enrolment until the end of data analysis (5 years)]
Eligibility criteria
Inclusion criteria
- 2-18 years old
- referred for diagnostic PSG to assess for OSA at their local tertiary care centre
- parent/caregiver has access to mobile technology
Exclusion criteria
- previous diagnosis of sleep-disordered breathing based on PSG in the last five years
- unable to cooperate for PSG
- clinician-suspected presence of central sleep apnea or central hypoventilation
- genetic or congenital syndrome
- non-verbal
- use of PAP therapy or tracheostomy
- parent/caregiver does not speak English or French
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Canada · 4 centers
- Stollery Children's Hospital — Edmonton
- Children's Hospital of Eastern Ontario — Ottawa
- The Hospital for Sick Children — Toronto
- Montreal Children's Hospital — Montreal
Identifiers
NCT: NCT06801366 · 24/19CTO · 517815