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Wearable Technologies for Sleep in Children and Adolescents

NCT06237842 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2025-12-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • SleepUp Tecnologia em Saúde Ltda

    lead INDUSTRY

Principal Investigators

  • Leticia Soster, PhD · Instituto da Criança do Hospital da Clínicas- FMUSP

  • Anna Monazzi, PhD · Instituto da Criança do Hospital da Clínicas- FMUSP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-22
Primary Completion
2026-12-01
Completion
2027-05-01
FDA Device
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06237842 on ClinicalTrials.gov