Wearable Technologies for Sleep in Children and Adolescents

Evaluation of Wearable Technologies for Sleep Monitoring 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.

Study Overview

• Status: Recruiting
• Conditions: Sleep; Pediatric Sleep Apnea
• Intervention / Treatment: Diagnostic test: Diagnostic Test: EEG headband+Ring oximeter (RO)+Actigraphy (ACT)

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 Type: Observational
• Enrollment (Estimated): 48

Contacts and Locations

• Study Contact: Name: Leticia Soster, PhD; Phone Number: +55 11 2661-8500; Email: sonoinfantilicr@gmail.com

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05403-000
      • Recruiting
      • Instituto da Criança do Hospital da Clínicas - FMUSP
      • Contact: Leticia Soster, PhD; Phone Number: +55 11 2661-8500; Email: sonoinfantilicr@gmail.com
      • Contact: Anna Monazzi; Phone Number: +55 11 2661-8500; Email: sonoinfantilicr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Children/adolescents who come to the Sleep Laboratory of the Children's Institute of the University of São Paulo for a polysomnography test.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy participants; Participants from 3 to 18 years old, from both genders and with no sleep disorders	Diagnostic test: 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.
Participants with sleep disorders; Participantes with one sleep disorder or complaint.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SleepUp Tecnologia em Saúde Ltda
• Investigators: Principal Investigator: Leticia Soster, PhD, Instituto da Criança do Hospital da Clínicas- FMUSP; Study Director: Anna Monazzi, PhD, Instituto da Criança do Hospital da Clínicas- FMUSP

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: EEG; Pediatric sleep; Adolescent sleep
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes
• Other Study ID Numbers: SleepUp_#03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The dissemination of Individual Participant Data (IPD) from this study is strictly limited by restrictions on the release of intellectual property, concerns regarding participant privacy and confidentiality, and the absence of explicit consent for extensive data sharing. However, upon reasonable request and subject to approval by the study's principal investigator, anonymized datasets may be provided to qualified researchers. It is imperative that requests include a thorough research proposal and a rationale that substantiates the need for the resources in question.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No