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临床试验/NCT06237842
NCT06237842招募中不适用

Evaluation of Wearable Technologies for Sleep Monitoring in Children and Adolescents

SleepUp Tecnologia em Saúde Ltda1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
48
试验地点
1
主要终点
Wake after sleep onset

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

Wake after sleep onset

时间窗: Immediately after the polysomnography.

Total time of epochs staged as "wake" after sleep latency.

Total time for each sleep stage

时间窗: Immediately after the polysomnography.

Time corresponding to epochs staged as each of the sleep stages (N1, N2, N3 and REM)

Percentage each sleep stage

时间窗: Immediately after the polysomnography.

Percentage corresponding to epochs staged as each of the sleep stages (N1, N2, N3 and REM), in comparison with total sleep time.

Total sleep time

时间窗: Immediately after the polysomnography.

Total time of epochs staged as sleep.

Sleep Latency

时间窗: Immediately after the polysomnography.

Time from the beginning of the polysomnographic record until the first epoch of sleep.

Sleep efficiency

时间窗: Immediately after the polysomnography.

Percentage of sleep in relation to total record/bed time.

Latency to REM sleep

时间窗: Immediately after the polysomnography.

Time from sleep latency until the first epoch of REM sleep.

次要结局

未报告次要终点

研究者

发起方
SleepUp Tecnologia em Saúde Ltda
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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