- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06801366
VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children (VIDEO)
January 5, 2026 updated by: Sherri Katz, Children's Hospital of Eastern Ontario
VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children (VIDEO)
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
625
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sherri Katz
- Phone Number: (613) 737-7600
- Email: skatz@cheo.on.ca
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada
- Not yet recruiting
- Stollery Children's Hospital
-
Contact:
- Joanna MacLean, Site Lead
- Phone Number: (780) 248-5584
- Email: joanna.maclean@ualberta.ca
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L1
- Recruiting
- Children's Hospital of Eastern Ontario
-
Contact:
- Sherri Katz, Principal Investigator
- Phone Number: 2956 613-737-7600
- Email: skatz@cheo.on.ca
-
Contact:
- Refika Ersu, Co-Principal Investigator
- Email: rersu@cheo.on.ca
-
Toronto, Ontario, Canada
- Recruiting
- The Hospital for Sick Children
-
Contact:
- Reshma Amin, Site Lead
- Phone Number: 415683 416-813-7654
- Email: reshma.amin@sickkids.ca
-
-
Quebec
-
Montreal, Quebec, Canada
- Recruiting
- Montreal Children's Hospital
-
Contact:
- David Zielinski, Site Lead
- Phone Number: 514-412-4400
- Email: david.zielinski@muhc.mcgill.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
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)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children with suspected Obstructive Sleep Apnea
Children referred for polysomnography (PSG) to investigate symptoms of obstructive sleep apnea (OSA).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrolment to end of data analysis (5 years).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrolment until the end of data analysis (5 years)
|
|
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.
|
From enrolment until the end of data analysis (5 years)
|
|
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.
|
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
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.
|
From enrolment until the end of data analysis (5 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2025
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2029
Study Registration Dates
First Submitted
January 24, 2025
First Submitted That Met QC Criteria
January 24, 2025
First Posted (Actual)
January 30, 2025
Study Record Updates
Last Update Posted (Actual)
January 7, 2026
Last Update Submitted That Met QC Criteria
January 5, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24/19CTO
- 517815 (Other Grant/Funding Number: CIHR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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