Recruiting

Smartphone Video Screening

Sponsor:

Children's Hospital of Eastern Ontario

Code:

NCT06801366

Conditions

Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Interventions

Parent-recorded smartphone video clips

Study Details

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.

Conditions

Obstructive Sleep Apnea (OSA)

Study ID

NCT06801366

Start date

Mar 18, 2025

Status verified date

Jan, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

625 participants

Anticipated

Interventions and Outcome Measures

Arms

Children with suspected Obstructive Sleep Apnea

Children referred for polysomnography (PSG) to investigate symptoms of obstructive sleep apnea (OSA).

Interventions

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.

Primary outcome measure

  • Diagnostic performance of video clips [ Time Frame: From enrolment to end of data analysis (5 years). ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital of Eastern Ontario

Recruiting

Ottawa, Ontario, Canada, K1H 8L1

Contacts

Sherri Katz, Principal Investigator

613-737-7600skatz@cheo.on.ca

Refika Ersu, Co-Principal Investigator

rersu@cheo.on.ca

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada

Contacts

Montreal Children's Hospital

Recruiting

Montreal, Quebec, Canada

Contacts

More Information

Sponsor

Children's Hospital of Eastern Ontario

Last update posted

Jan 7, 2026

Last verified

Jan, 2026

Keywords

  • obstructive sleep apnea
  • polysomnography
  • videos

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital of Eastern Ontario on 2026-01-07.