Obstructive Sleep Apnea (OSA)VIDEONCT06801366
VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children
An observational study of Obstructive Sleep Apnea (OSA), run by Children's Hospital of Eastern Ontario at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Parent-recorded smartphone video clips
- How many people
- 625 participants
- Where
- 4 sitesCanada
- Study dates
- 18 Mar 2025to 1 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Child, Adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Not yet recruiting
Stollery Children's Hospital
Edmonton, Alberta
Joanna MacLean, Site Lead, (780) 248-5584, joanna.maclean@ualberta.ca
- Recruiting
Montreal Children's Hospital
Montreal, Quebec
David Zielinski, Site Lead, 514-412-4400, david.zielinski@muhc.mcgill.ca
- Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Sherri Katz, Principal Investigator, 613-737-7600 ext. 2956, skatz@cheo.on.ca
Refika Ersu, Co-Principal Investigator, rersu@cheo.on.ca
- Recruiting
The Hospital for Sick Children
Toronto, Ontario
Reshma Amin, Site Lead, 416-813-7654 ext. 415683, reshma.amin@sickkids.ca
About this study
Official title: 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.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Parent-recorded smartphone video clips
- Keywords
- obstructive sleep apnea, polysomnography, videos
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-recorded smartphone video clipsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Children with suspected Obstructive Sleep Apnea | Children referred for polysomnography (PSG) to investigate symptoms of obstructive sleep apnea (OSA). Receives: Diagnostic Test: Parent-recorded smartphone video clips |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrolment to end of data analysis (5 years).
Secondary outcomes (4)
Specificity of video clips
To determine the specificity of video clips for diagnosis of moderate-severe OSA, if sensitivity is held at 0.90.
Measured: From enrolment until the end of data analysis (5 years)
Sensitivity of video clips
To determine the sensitivity of video clips for diagnosis of moderate-severe OSA, if specificity is held at 0.90.
Measured: From enrolment until the end of data analysis (5 years)
The added benefit of oximetry to the accuracy of video clips
To determine the added benefit of oximetry to the specificity and sensitivity of the video clips, if each is individually held at 0.90.
Measured: 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
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.
Measured: From enrolment until the end of data analysis (5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start18 Mar 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherri Katz, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801366
- Sponsor's protocol ID
- 24/19CTO
- Other IDs
- 517815
- Acronym
- VIDEO
- Status last verified
- Jan 2026
- First submitted
- 24 Jan 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children (VIDEO)
- ClinicalTrials.gov ID
- NCT06801366
- Acronym / sponsor ID
- VIDEO / 24/19CTO
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- obstructive sleep apnea, polysomnography, videos
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 625 participants (estimated)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with suspected Obstructive Sleep Apnea | – | Diagnostic Test: Parent-recorded smartphone video clipsChildren referred for polysomnography (PSG) to investigate symptoms of obstructive sleep apnea (OSA). |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent-recorded smartphone video clipsParents 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. | Diagnostic test | Children with suspected Obstructive Sleep Apnea |
Primary outcome
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.
4 secondary outcomes
Specificity of video clips
Time frame: 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)
The added benefit of oximetry to the accuracy of video clips
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA), run by Children's Hospital of Eastern Ontario at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherri Katz ((613) 737-7600, skatz@cheo.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of video clips (time frame: From enrolment to end of data analysis (5 years).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.