Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06801366

VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stollery Children's Hospital, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Diagnostic performance of video clips

    Time frame: From enrolment to end of data analysis (5 years).

    Evaluate the diagnostic accuracy of video clips compared to PSG in the detection of moderate-severe OSA. Estimate the area under the ROC curve.

Secondary outcomes

  1. Specificity of video clips

    Time frame: From enrolment until the end of data analysis (5 years)

    To determine the specificity of video clips for diagnosis of moderate-severe OSA, if sensitivity is held at 0.90.

  2. Sensitivity of video clips

    Time frame: From enrolment until the end of data analysis (5 years)

    To determine the sensitivity of video clips for diagnosis of moderate-severe OSA, if specificity is held at 0.90.

  3. The added benefit of oximetry to the accuracy of video clips

    Time frame: From enrolment until the end of data analysis (5 years)

    To determine the added benefit of oximetry to the specificity and sensitivity of the video clips, if each is individually held at 0.90.

  4. 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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sherri Katz

CONTACT

[email protected]

(613) 737-7600

Sponsors and collaborators

Lead sponsor

Children's Hospital of Eastern Ontario

Other

Registry information

Official study title

VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children (VIDEO)

Acronym: VIDEO

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jan 30, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.