Clinical trial NCT06801366: VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children
Official title: VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children (VIDEO)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obstructive Sleep Apnea (OSA)
Keywords: obstructive sleep apnea
polysomnography
videos
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 625
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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

Primary outcomes:
measure: Diagnostic performance of video clips
timeFrame: From enrolment to end of data analysis (5 years).
Secondary outcomes:
measure: Specificity of video clips
timeFrame: From enrolment until the end of data analysis (5 years)
measure: Sensitivity of video clips
timeFrame: From enrolment until the end of data analysis (5 years)
measure: The added benefit of oximetry to the accuracy of video clips
timeFrame: From enrolment until the end of data analysis (5 years)
measure: The added benefit of the Pediatric Sleep Questionnaire (PSQ) and oximetry to the accuracy of video clips
timeFrame: From enrolment until the end of data analysis (5 years)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
Study officials:
References: