Down SyndromeUPLOADNCT04022460
Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)
An observational study of Down Syndrome and Obstructive Sleep Apnea, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
This study aims to see if mobile video clips (smartphone recordings) can be used to screen children with Down syndrome to identify those at highest risk of obstructive sleep apnea (OSA), so they can be prioritized for an earlier sleep study. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Down Syndrome, Obstructive Sleep Apnea, Child
- What is being tested?
- Video clip assessment, Polysomnography (sleep study) and Educational webinar
- How many people
- 141 participants
- Where
- 1 siteCanada
- Study dates
- 17 Sep 2019to Dec 2026
- 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
- No healthy volunteers
- Child, Adult
Study population: The study population will consist of children with Down syndrome who have not previously been diagnosed with sleep-disordered breathing. We will approach children followed at the CHEO Down Syndrome clinic to participate in this study. All children within CHEO's catchment area will be considered eligible for this study.
Who may be able to join
- Diagnosis of Down syndrome
- Within the catchment area of the Children's Hospital of Eastern Ontario Down Syndrome clinic
Who cannot join
- Previous diagnosis of sleep-disordered breathing on polysomnography
- No access to mobile technology to record video clips
- Children unable to cooperate for polysomnography
- Caregiver does not speak French or English
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to see if mobile video clips (smartphone recordings) can be used to screen children with Down syndrome to identify those at highest risk of obstructive sleep apnea (OSA), so they can be prioritized for an earlier sleep study. Parents will be asked to record short video clips of their child sleeping, and then rate whether they think their child has OSA. Later, children will undergo a sleep study to compare to the ratings.
Read the detailed description
Children with Down syndrome have approximately a 50% chance of developing obstructive sleep apnea (OSA) in their lifetime. OSA is a serious condition where a person stops breathing periodically during sleep; it is associated with high blood pressure, behavioural issues, and lower quality of life. Early diagnosis and treatment is critical, but the best way to diagnose OSA, a 'sleep study', is in short supply. Given the limited resources, this study aims to see if mobile video clips (smartphone recordings) can be used to screen children with Down syndrome to identify those at highest risk of OSA, so they can be prioritized for an earlier sleep study.
Parents of children with Down syndrome, recruited from clinic, will be asked to record short video clips of their child sleeping. Parents will independently rate whether they think their child has OSA and how severe it is, based on the videos, as will two clinicians. Parents will also watch an educational webinar and be asked to re-rate the presence and severity of OSA in their child, to see if the webinar improves their accuracy. Finally, children will undergo a sleep study to compare to the ratings. This study will help determine whether videos can be used to accurately screen for OSA in this high risk population, prioritizing children for earlier diagnosis and treatment.
- Conditions
- Down Syndrome, Obstructive Sleep Apnea, Child
- Being tested
- Video clip assessment, Polysomnography (sleep study), Educational webinar
- Keywords
- Polysomnography, Pediatric, Down syndrome, Obstructive sleep apnea, Screening tool, Mobile technology
- Medical subject headings
- Down Syndrome, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video clip assessmentDiagnostic test
Parents will take short video clips of their child sleeping at night. They will be asked to review the video clips and rate whether they think their child has obstructive sleep apnea (OSA), and if so, how severe it is. Two clinicians will review the video clips on a separate night.
Polysomnography (sleep study)Diagnostic test
Children will undergo a polysomnography as the gold standard test to assess for OSA.
Educational webinarOther
After evaluating the video clips of their child sleeping, parents will watch an educational webinar on OSA in children with Down syndrome and how to recognize symptoms.
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental screening assessment of presence/absence of OSA based on homemade video clip
Questionnaire developed at CHEO by Pediatric Respirologists and Otolaryngologists. The question of interest is "Do you think your child has obstructive sleep apnea?" The reviewer (a parent) will choose 'Yes' or 'No' after reviewing the homemade video clips. This is a dichotomous outcome with 'Yes' considered as the highest score. The gold standard reference test will be a polysomnography.
Measured: 1 day
Secondary outcomes (3)
Parental assessment of severity of OSA based on homemade video clip
Questionnaire developed at CHEO by Pediatric Respirologists and Otolaryngologists. The question of interest is "Do you believe the severity of the obstructive sleep apnea is: a) Mild, b) Moderate, or c) Severe ?" This question will only appear to parents who chose 'Yes' for the primary outcome. The reviewer will answer the question after reviewing the homemade video clips. This is an ordinal outcome with 'Mild' being considered the lowest score (1), and 'Severe' being considered the highest score (3). The gold standard reference test will be a polysomnography.
Measured: 1 day
Physician screening assessment of presence/absence of OSA based on homemade video clip
Questionnaire developed at CHEO by Pediatric Respirologists and Otolaryngologists. The question of interest is "Do you think your child has obstructive sleep apnea?" Two physicians will independently choose 'Yes' or 'No' after reviewing the homemade video clips. This is a dichotomous outcome with 'Yes' considered as the highest score. The gold standard reference test will be a polysomnography.
Measured: 1 day
Physician assessment of severity of OSA based on homemade video clip
Questionnaire developed at CHEO by Pediatric Respirologists and Otolaryngologists. The question of interest is "Do you believe the severity of the obstructive sleep apnea is: a) Mild, b) Moderate, or c) Severe ?" This question will only appear to physicians who choose 'Yes' for Outcome #3. The reviewer will answer the question after reviewing the homemade video clips. This is an ordinal outcome with 'Mild' being considered the lowest score (1), and 'Severe' being considered the highest score (3). The gold standard reference test will be a polysomnography.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start17 Sep 2019
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies 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
- 141 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Sherri Katz, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022460
- Sponsor's protocol ID
- 19/30X
- Acronym
- UPLOAD
- Status last verified
- Mar 2026
- First submitted
- 15 Jul 2019
- Last updated
- 18 Mar 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 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)
- ClinicalTrials.gov ID
- NCT04022460
- Acronym / sponsor ID
- UPLOAD / 19/30X
- Conditions
- Down Syndrome, Obstructive Sleep Apnea, Child
- Keywords
- Polysomnography, Pediatric, Down syndrome, Obstructive sleep apnea, Screening tool, Mobile technology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 141 participants (estimated)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jul 2019 (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.
This study aims to see if mobile video clips (smartphone recordings) can be used to screen children with Down syndrome to identify those at highest risk of obstructive sleep apnea (OSA), so they can be prioritized for an earlier sleep study. Parents will be asked to record short video clips of their child sleeping, and then rate whether they think their child has OSA. Later, children will undergo a sleep study to compare to the ratings.
Detailed description
Children with Down syndrome have approximately a 50% chance of developing obstructive sleep apnea (OSA) in their lifetime. OSA is a serious condition where a person stops breathing periodically during sleep; it is associated with high blood pressure, behavioural issues, and lower quality of life. Early diagnosis and treatment is critical, but the best way to diagnose OSA, a 'sleep study', is in short supply. Given the limited resources, this study aims to see if mobile video clips (smartphone recordings) can be used to screen children with Down syndrome to identify those at highest risk of OSA, so they can be prioritized for an earlier sleep study.
Parents of children with Down syndrome, recruited from clinic, will be asked to record short video clips of their child sleeping. Parents will independently rate whether they think their child has OSA and how severe it is, based on the videos, as will two clinicians. Parents will also watch an educational webinar and be asked to re-rate the presence and severity of OSA in their child, to see if the webinar improves their accuracy. Finally, children will undergo a sleep study to compare to the ratings. This study will help determine whether videos can be used to accurately screen for OSA in this high risk population, prioritizing children for earlier diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of children with Down syndrome who have not previously been diagnosed with sleep-disordered breathing. We will approach children followed at the CHEO Down Syndrome clinic to participate in this study. All children within CHEO's catchment area will be considered eligible for this study.
Key inclusion criteria (2 listed)
- Diagnosis of Down syndrome
- Within the catchment area of the Children's Hospital of Eastern Ontario Down Syndrome clinic
Key exclusion criteria (4 listed)
- Previous diagnosis of sleep-disordered breathing on polysomnography
- No access to mobile technology to record video clips
- Children unable to cooperate for polysomnography
- Caregiver does not speak French or English
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 |
|---|---|---|
| Video clip assessmentParents will take short video clips of their child sleeping at night. They will be asked to review the video clips and rate whether they think their child has obstructive sleep apnea (OSA), and if so, how severe it is. Two clinicians will review the video clips on a separate night. | Diagnostic test | – |
| Polysomnography (sleep study)Children will undergo a polysomnography as the gold standard test to assess for OSA. | Diagnostic test | – |
| Educational webinarAfter evaluating the video clips of their child sleeping, parents will watch an educational webinar on OSA in children with Down syndrome and how to recognize symptoms. | Other | – |
Primary outcome
Parental screening assessment of presence/absence of OSA based on homemade video clip
Time frame: 1 day
Questionnaire developed at CHEO by Pediatric Respirologists and Otolaryngologists. The question of interest is "Do you think your child has obstructive sleep apnea?" The reviewer (a parent) will choose 'Yes' or 'No' after reviewing the homemade video clips. This is a dichotomous outcome with 'Yes' considered as the highest score. The gold standard reference test will be a polysomnography.
3 secondary outcomes
Parental assessment of severity of OSA based on homemade video clip
Time frame: 1 day
Physician screening assessment of presence/absence of OSA based on homemade video clip
Time frame: 1 day
Physician assessment of severity of OSA based on homemade video clip
Time frame: 1 day
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 18 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome and Obstructive Sleep Apnea, run by Children's Hospital of Eastern Ontario at 1 site 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental screening assessment of presence/absence of OSA based on homemade video clip (time frame: 1 day). 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 18 Mar 2026.