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NCT Number: NCT06237842

Wearable Technologies for Sleep in Children and Adolescents

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.

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Key information

Conditions

Sleep Pediatric Sleep Apnea

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • None.

Treatment and study plan

Diagnostic Test: EEG headband+Ring oximeter (RO)+Actigraphy (ACT)

Diagnostic Test

Combination of ACT+RO+EEG. This is not an intervention, but rather a combination of devices to be tested regarding its diagnostic validity.

Primary outcomes

  1. Sleep Latency

    Time frame: Immediately after the polysomnography.

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

  2. Total sleep time

    Time frame: Immediately after the polysomnography.

    Total time of epochs staged as sleep.

  3. Sleep efficiency

    Time frame: Immediately after the polysomnography.

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

  4. Wake after sleep onset

    Time frame: Immediately after the polysomnography.

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

  5. Latency to REM sleep

    Time frame: Immediately after the polysomnography.

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

  6. Total time for each sleep stage

    Time frame: Immediately after the polysomnography.

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

  7. Percentage each sleep stage

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Leticia Soster, PhD

CONTACT

[email protected]

+55 11 2661-8500

Sponsors and collaborators

Lead sponsor

SleepUp Tecnologia em Saúde Ltda

Industry

Registry information

Official study title

Evaluation of Wearable Technologies for Sleep Monitoring in Children and Adolescents

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 2, 2024
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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