Wearable Technologies for Sleep in Children and Adolescents

NCT06237842 | Recruiting FDA Device

• 1 other identifier: SleepUp_#03
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Pediatric Sleep Apnea

Keywords

Pediatric sleep; Adolescent sleep; EEG

Outcome Measures

Primary Outcomes (7)

• 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.

Study Arms (2)

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)

Participants with sleep disorders

Participantes with one sleep disorder or complaint.

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

Interventions

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.

Healthy participants; Participants with sleep disorders

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• All genders
• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• SleepUp Tecnologia em Saúde Ltda: lead

Study Sites (1)

Instituto da Criança do Hospital da Clínicas - FMUSP

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Study Officials

• Leticia Soster, PhD

  Instituto da Criança do Hospital da Clínicas- FMUSP

  PRINCIPAL INVESTIGATOR

• Anna Monazzi, PhD

  Instituto da Criança do Hospital da Clínicas- FMUSP

  STUDY DIRECTOR

Central Study Contacts

Leticia Soster, PhD

CONTACT

+55 11 2661-8500; sonoinfantilicr@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 2, 2024
• Study Start: November 22, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)