NCT06801366 VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children
| NCT ID | NCT06801366 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Eastern Ontario |
| Condition | Obstructive Sleep Apnea (OSA) |
| Study Type | OBSERVATIONAL |
| Enrollment | 625 participants |
| Start Date | 2025-03-18 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 625 participants in total. It began in 2025-03-18 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06801366 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 18 Years, studying Obstructive Sleep Apnea (OSA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06801366 currently recruiting?
Yes, NCT06801366 is actively recruiting participants. Contact the research team at skatz@cheo.on.ca for enrollment information.
Where is the NCT06801366 trial being conducted?
This trial is being conducted at Edmonton, Canada, Ottawa, Canada, Toronto, Canada, Montreal, Canada.
Who is sponsoring the NCT06801366 clinical trial?
NCT06801366 is sponsored by Children's Hospital of Eastern Ontario. The trial plans to enroll 625 participants.