Идёт набор NCT06237842

Wearable Technologies for Sleep in Children and Adolescents

— Наблюдательное Sleep Pediatric Sleep Apnea

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: Diagnostic Test: EEG headband+Ring oximeter (RO)+Actigraphy (ACT).
Кому может быть актуально: Состояния в реестре: Sleep, Pediatric Sleep Apnea. Базовые параметры: 3 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: Бразилия
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

Evaluation of Wearable Technologies for Sleep Monitoring in Children and Adolescents

Обзор

This study aims to evaluate the viability of wearable and portable technologies for sleep staging in children and adolescents. The results will be compared with polysomnography, in order to achieve clinical and diagnostic validation. Three domains of devices will be used: movement sensors, wearable EEG band and pulse oximetry. The project will include individuals between the ages of 3 and 18 who reside in São Paulo city and undergo a polysomnography test at the Sleep Laboratory of the Children's Institute of the Hospital das Clínicas of the University of São Paulo.

Подробное описание

This study aims to evaluate the viability of the combined use of wearable and portable technologies for sleep staging. The results will be compared with polysomnography, in order to achieve clinical and diagnostic validation. Three domains of devices will be used:

* Movement sensors: Devices equipped with movement sensors (such as an accelerometer) able to monitor movement over the using period, converting this information in data related to the sleep-wakefulness cycle. In this category, the reference devices are the actimeters/actigraphs (ACT). Its use is recommended by the American Academy of Sleep Medicine to the diagnosis of insomnia and circadian sleep disorders, and should be used for 3 to 14 consecutive days. Other wearable devices, such as smartwatches, are also used with the same purpose, although not validated for clinical use. * Wearable EEG band: EEG is a mandatory feature for type-1 polysomnography and a requirement for regular sleep staging. The project will utilize a wearable EEG band in combination with actigraphy and a ring oximeter to improve the estimation of sleep stages. This study will test wearable EEG bands with the following minimal specifications: dry EEG electrodes (no need for paste, gel, or other conductors), presented as a headband or stripe, a minimal sampling rate of 500Hz, noise, high and low filters, a battery lasting at least 8 hours, a maximum weight of 200g (including the whole device), and support for Bluetooth connection. * Ring oximeter: The project will utilize a ring oximter to record the overnight blood oxygen levels, heart rates, and body movements.

Вмешательства

Диагностический тест Diagnostic Test: EEG headband+Ring oximeter (RO)+Actigraphy (ACT)
Combination of ACT+RO+EEG. This is not an intervention, but rather a combination of devices to be tested regarding its diagnostic validity.

Первичные конечные точки

Sleep Latency [Срок оценки: Immediately after the polysomnography.]
Total sleep time [Срок оценки: Immediately after the polysomnography.]
Sleep efficiency [Срок оценки: Immediately after the polysomnography.]
Wake after sleep onset [Срок оценки: Immediately after the polysomnography.]
Latency to REM sleep [Срок оценки: Immediately after the polysomnography.]
Total time for each sleep stage [Срок оценки: Immediately after the polysomnography.]
Percentage each sleep stage [Срок оценки: Immediately after the polysomnography.]

Критерии участия

Критерии включения

All genders
3 to 18 years olnde
Resident in the city of São Paulo
Candidate to perfome a polysomnography test at the Sleep Laboratory of the Children's Institute of the Hospital das Clínicas of the University of São Paulo.