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| ID | Type | Description | Link |
|---|---|---|---|
| 517815 | Other Grant/Funding Number | CIHR |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with suspected Obstructive Sleep Apnea | Children referred for polysomnography (PSG) to investigate symptoms of obstructive sleep apnea (OSA). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parent-recorded smartphone video clips | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrolment to end of data analysis (5 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of video clips | To determine the specificity of video clips for diagnosis of moderate-severe OSA, if sensitivity is held at 0.90. | From enrolment until the end of data analysis (5 years) |
| Sensitivity of video clips |
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Inclusion Criteria:
Exclusion Criteria:
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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)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sherri Katz | Contact | (613) 737-7600 | skatz@cheo.on.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stollery Children's Hospital | Not yet recruiting | Edmonton | Alberta | Canada |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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To determine the sensitivity of video clips for diagnosis of moderate-severe OSA, if specificity is held at 0.90.
| 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. | 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. | From enrolment until the end of data analysis (5 years) |
| Children's Hospital of Eastern Ontario | Recruiting | Ottawa | Ontario | K1H 8L1 | Canada |
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| The Hospital for Sick Children | Recruiting | Toronto | Ontario | Canada |
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| Montreal Children's Hospital | Recruiting | Montreal | Quebec | Canada |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |