Portable Sleep Monitors in Children With Autism Spectrum Disorder
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: Portable sleep monitor (Nox T3s).
- Кому может быть актуально
- Состояния в реестре: Autism Spectrum Disorder (ASD), Obstructive Sleep Apnea (OSA). Базовые параметры: 6 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Accuracy of Portable Sleep Monitoring for Children With Autism Spectrum Disorder
Обзор
The goal of this study is to evaluate the ability of a portable sleep monitor to detect obstructive sleep apnea in children with autism spectrum disorder (ASD). The main study objectives are to: 1. Evaluate the correlation between the obstructive apnea-hypopnea index (OAHI) on a portable sleep monitor and an in-laboratory polysomnogram (PSG); 2. Determine the sensitivity and specificity of a portable sleep monitor to diagnose obstructive sleep apnea (OSA); 3. Evaluate patient and family preferences for sleep testing.
Подробное описание
Sleep disorders are highly prevalent in children with ASD, with as many as 80% of children reporting poor sleep. To identify the cause of poor sleep, many children will require a sleep study (polysomnogram; PSG), which is an overnight study done at the hospital using many different sensors to measure sleep and breathing. The PSG is the gold standard diagnostic test for obstructive sleep apnea (OSA) and measures the rate of obstructive respiratory events during sleep (obstructive apnea-hypopnea index; OAHI) which is crucial for treatment decision-making. However, PSGs are challenging for children with ASD due to the disrupted routine, burden and stress, and intolerance to the PSG setup. Further, diagnosis may be delayed up to 2 years due to a lack of pediatric sleep facilities in Canada, with pronounced geographical disparities. Although sleep disturbances are prevalent amongst children with ASD, there are significant inequities in accessing pediatric sleep medicine care and diagnostic testing. Alternative, simpler diagnostic testing is needed.
We will evaluate a portable sleep monitor as the first step towards establishing home sleep apnea testing in children with ASD. We will conduct a feasibility study testing the Nox T3s portable sleep monitor alongside the traditional in-hospital polysomnogram to compare the ability of the Nox T3s to identify obstructive sleep apnea in children with ASD. We will also conduct qualitative interviews with families to gather insight on participant and family preferences for sleep testing to better address the needs of children with ASD.
Вмешательства
- Устройство Portable sleep monitor (Nox T3s)
Participants will test the Nox T3s portable sleep monitor concurrently during their in-hospital clinical polysomnogram.
Первичные конечные точки
- Obstructive Apnea-Hypopnea Index (OAHI) measured from the portable sleep monitor and from the polysomnogram (PSG) [Срок оценки: Baseline]
Вторичные конечные точки (12)
- Patient and Family Preferences [Срок оценки: 0-3 months after the baseline PSG]
- Insomnia Questionnaire [Срок оценки: +/- 1 week from baseline PSG sleep test]
- Chronotype Questionnaire [Срок оценки: +/- 1 week from baseline PSG sleep test]
- Chronotype Questionnaire [Срок оценки: +/- 1 week from baseline PSG sleep test]
- Chronotype Questionnaire [Срок оценки: +/- 1 week from baseline PSG sleep test]
- Sleep Questionnaire [Срок оценки: +/- 1 week from baseline PSG sleep test]
- Psychological Scale (Emotional Symptoms) [Срок оценки: +/- 1 week from baseline PSG sleep test]
- Psychological Scale (Conduct Problems) [Срок оценки: +/- 1 week from baseline PSG sleep test]
- Psychological Scale (Hyperactivity/inattention) [Срок оценки: +/- 1 week from baseline PSG sleep test]
- Psychological Scale (Peer Relationship Problems) [Срок оценки: +/- 1 week from baseline PSG sleep test]
- Psychological Scale (Pro-Social) [Срок оценки: +/- 1 week from baseline PSG sleep test]
- Psychological Scale (Total Difficulties) [Срок оценки: +/- 1 week from baseline PSG sleep test]
Критерии участия
Критерии включения
- Children between 6 to 18 years of age, AND;
- Children diagnosed with autism spectrum disorder, AND;
- Children who will be undergoing a polysomnogram (PSG) for the first time, AND;
- Caregiver willing to complete questionnaires about child's sleep and behavior
Критерии исключения
- Children who are currently using respiratory therapy
- Children who have previously completed a PSG
- Caregiver unwilling to complete questionnaires about child's sleep and behavior
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Канада · 1 центр
- British Columbia Children's Hospital — Vancouver
Идентификаторы
NCT: NCT07367022 · H25-00532