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Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD) (UPLOAD)

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ClinicalTrials.gov Identifier: NCT04022460
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : July 31, 2020
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Sherri Katz, Children's Hospital of Eastern Ontario

Tracking Information
First Submitted Date July 15, 2019
First Posted Date July 17, 2019
Last Update Posted Date July 31, 2020
Actual Study Start Date September 17, 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 31, 2019)
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.
Original Primary Outcome Measures
 (submitted: July 15, 2019)
Parental screening assessment of presence/absence of OSA based on homemade video clip [ Time Frame: 1 day ]
Based on the homemade video clips, parents will report whether they think their child has OSA (yes/no). The gold standard reference test will be a polysomnography.
Change History
Current Secondary Outcome Measures
 (submitted: July 31, 2019)
  • Parental assessment of severity 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 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.
  • Physician 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?" 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.
  • Physician assessment of severity 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 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.
Original Secondary Outcome Measures
 (submitted: July 15, 2019)
  • Parental assessment of severity of OSA based on homemade video clip [ Time Frame: 1 day ]
    Based on the homemade video clips, parents will rate how severe they think their child's OSA is (not applicable/mild/moderate/severe). The gold standard reference test will be a polysomnography.
  • Physician screening assessment of presence/absence of OSA based on homemade video clip [ Time Frame: 1 day ]
    Based on the homemade video clips, two physicians will independently rate whether they think the child has OSA (yes/no). The gold standard reference test will be a polysomnography.
  • Physician assessment of severity of OSA based on homemade video clip [ Time Frame: 1 day ]
    Based on the homemade video clips, physicians will rate how severe they think the child's OSA is (not applicable/mild/moderate/severe). The gold standard reference test will be a polysomnography.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)
Official Title Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)
Brief 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. 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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.
Condition
  • Down Syndrome
  • Obstructive Sleep Apnea
  • Child
Intervention
  • Diagnostic Test: Video clip assessment
    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.
  • Diagnostic Test: Polysomnography (sleep study)
    Children will undergo a polysomnography as the gold standard test to assess for OSA.
  • Other: Educational webinar
    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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 15, 2019)
141
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of Down syndrome
  • Within the catchment area of the Children's Hospital of Eastern Ontario Down Syndrome clinic

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Henrietta Blinder 613-737-7600 ext 4026 hblinder@cheo.on.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04022460
Other Study ID Numbers 19/30X
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Sherri Katz, Children's Hospital of Eastern Ontario
Study Sponsor Children's Hospital of Eastern Ontario
Collaborators The Physicians' Services Incorporated Foundation
Investigators Not Provided
PRS Account Children's Hospital of Eastern Ontario
Verification Date July 2020