An observational study in Obstructive Sleep Apnea (OSA), sponsored by Children's Hospital of Eastern Ontario. Recruiting at 4 sites in Canada. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Children's Hospital of Eastern Ontario · Observational
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 625 is above the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Children's Hospital of Eastern Ontario is the lead sponsor of 84 studies on the registry; 10 are open to participants now.
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4 Canadian tertiary pediatric centres: Children's Hospital of Eastern Ontario (Ottawa), The Hospital for Sick Children (Toronto), Montreal Children's Hospital (Montreal), Stollery Children's Hospital (Edmonton)
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Exclusion Criteria:
Children referred for polysomnography (PSG) to investigate symptoms of obstructive sleep apnea (OSA).
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.
Diagnostic performance of video clips
Evaluate the diagnostic accuracy of video clips compared to PSG in the detection of moderate-severe OSA. Estimate the area under the ROC curve.
Time frame: From enrolment to end of data analysis (5 years).
Specificity of video clips
To determine the specificity of video clips for diagnosis of moderate-severe OSA, if sensitivity is held at 0.90.
Time frame: From enrolment until the end of data analysis (5 years)
Sensitivity of video clips
To determine the sensitivity of video clips for diagnosis of moderate-severe OSA, if specificity is held at 0.90.
Time frame: From enrolment until the end of data analysis (5 years)
The added benefit of oximetry to the accuracy of video clips
To determine the added benefit of oximetry to the specificity and sensitivity of the video clips, if each is individually held at 0.90.
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
To further determine the benefit of the PSQ in addition to oximetry and video clips in terms of specificity and sensitivity, if each is individually held at 0.90.
Time frame: From enrolment until the end of data analysis (5 years)
Started Mar 2025 (actual). Primary completion is estimated for Jul 2028, 39 months after the start.
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Children's Hospital of Eastern Ontario