VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children

NCT ID: NCT06801366

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

625 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-18

Study Completion Date

2029-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea (OSA)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Children with suspected Obstructive Sleep Apnea

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

Parent-recorded smartphone video clips

Intervention Type 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.

Interventions

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Parent-recorded smartphone video clips

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Eastern Ontario

OTHER

Sponsor Role lead

Responsible Party

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Sherri Katz

Division Chief of Pediatric Respirology and Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stollery Children's Hospital

Edmonton, Alberta, Canada

Site Status NOT_YET_RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Site Status RECRUITING

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status RECRUITING

Montreal Children's Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Sherri Katz

Role: CONTACT

(613) 737-7600

Facility Contacts

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Joanna MacLean, Site Lead

Role: primary

(780) 248-5584

Sherri Katz, Principal Investigator

Role: primary

613-737-7600 ext. 2956

Refika Ersu, Co-Principal Investigator

Role: backup

Reshma Amin, Site Lead

Role: primary

416-813-7654 ext. 415683

David Zielinski, Site Lead

Role: primary

514-412-4400

Other Identifiers

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517815

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

24/19CTO

Identifier Type: -

Identifier Source: org_study_id

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