Wearable Technologies for Sleep in Children and Adolescents

Active, not recruiting

• Conditions: Pediatric Sleep Apnea; Sleep

• Registration Number: NCT06237842
• Lead Sponsor: SleepUp Tecnologia em Saúde Ltda

Brief Summary

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, achieving a minimum of 85% sleep efficiency on the night of the test.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-02-02
• Study Start: 2024-11-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-12-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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.

Exclusion Criteria

• Individuals with sleep efficiency lower than 85% on the night in question.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wake after sleep onset	Immediately after the polysomnography.	Total time of epochs staged as "wake" after sleep latency.
Total time for each sleep stage	Immediately after the polysomnography.	Time corresponding to epochs staged as each of the sleep stages (N1, N2, N3 and REM)
Percentage each sleep stage	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	Immediately after the polysomnography.	Total time of epochs staged as sleep.
Sleep Latency	Immediately after the polysomnography.	Time from the beginning of the polysomnographic record until the first epoch of sleep.
Sleep efficiency	Immediately after the polysomnography.	Percentage of sleep in relation to total record/bed time.
Latency to REM sleep	Immediately after the polysomnography.	Time from sleep latency until the first epoch of REM sleep.

Trial Locations

Locations (1)

Instituto da Criança do Hospital da Clínicas - FMUSP; 🇧🇷 São Paulo, Brazil