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Идёт набор NCT06801366

VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children

— Наблюдательное Obstructive Sleep Apnea (OSA)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Parent-recorded smartphone video clips.
Кому может быть актуально
Состояния в реестре: Obstructive Sleep Apnea (OSA). Базовые параметры: 2 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

VIdeo Clips for Diagnostic Evaluation of Obstructive Sleep Apnea in Children (VIDEO)

Обзор

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.

Вмешательства

  • Диагностический тест 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.

Первичные конечные точки

  • Diagnostic performance of video clips [Срок оценки: From enrolment to end of data analysis (5 years).]
Вторичные конечные точки (4)
  • Specificity of video clips [Срок оценки: From enrolment until the end of data analysis (5 years)]
  • Sensitivity of video clips [Срок оценки: From enrolment until the end of data analysis (5 years)]
  • The added benefit of oximetry to the accuracy of video clips [Срок оценки: 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 [Срок оценки: From enrolment until the end of data analysis (5 years)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 4 центра
  • Stollery Children's Hospital — Edmonton
  • Children's Hospital of Eastern Ontario — Ottawa
  • The Hospital for Sick Children — Toronto
  • Montreal Children's Hospital — Montreal

Идентификаторы

NCT: NCT06801366 · 24/19CTO · 517815

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗