VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children

NCT06801366 | Recruiting

• 2 other identifiers: 24/19CTO517815
• Study Type: observational
• Target: 625
• Locations: 1 country
• Sites: 4

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)

Keywords

obstructive sleep apnea; polysomnography; videos

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (4)

• Specificity of video clips

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

• Sensitivity of video clips

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

• The added benefit of oximetry to the accuracy of video clips

  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

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

Study Arms (1)

Children with suspected Obstructive Sleep Apnea

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

Diagnostic Test: Parent-recorded smartphone video clips

Interventions

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.

Children with suspected Obstructive Sleep Apnea

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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)

You may qualify if:

• years old
• referred for diagnostic PSG to assess for OSA at their local tertiary care centre
• parent/caregiver has access to mobile technology

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead

Study Sites (4)

Stollery Children's Hospital

Edmonton, Alberta, Canada

NOT YET RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

Montreal Children's Hospital

Montreal, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Sherri Katz

CONTACT

(613) 737-7600; skatz@cheo.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief of Pediatric Respirology and Senior Scientist

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

CA (4)