Clinical trial Recruiting at 1 site Observational Ages 3 to 18

Wearable devices for tracking sleep in children and teens

Official title: Evaluation of Wearable Technologies for Sleep Monitoring in Children and Adolescents

Run by SleepUp Tecnologia em Saúde Ltda · NCT06237842 · Data updated 2026-11-12

This project will test whether movement sensors, a wearable EEG headband, and a ring oximeter can accurately track sleep stages in children and adolescents who are having a sleep lab test.

Quick facts

Study typeObservational
Ages3 Years to 18 Years
SexAll
Enrollment48 (estimated)
SponsorSleepUp Tecnologia em Saúde Ltda
Industry-sponsored
Locations1 site (São Paulo, São Paulo)
StatusRecruiting
StartedNovember 22, 2024
Main results expectedDecember 1, 2026
Study endsMay 1, 2027
Registry record updatedDecember 2, 2025
Trial IDNCT06237842 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children and adolescents 3 to 18 years old who live in São Paulo and are scheduled for polysomnography at the Children's Institute of Hospital das Clínicas (University of São Paulo) are ideal candidates.

Probably not a fit

Children who do not reside in São Paulo, are not undergoing polysomnography at the listed center, or who cannot tolerate wearing the devices are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Children and adolescents aged 3–18 who live in São Paulo and are scheduled for polysomnography at the Children's Institute will wear a combination of devices including actigraphy/movement sensors, a dry-electrode wearable EEG headband, and a ring pulse oximeter. Device-derived sleep staging will be compared directly to standard overnight polysomnography to judge clinical and diagnostic agreement. The wearable EEG band must meet minimum technical specifications (dry electrodes, ≥500 Hz sampling, ≥8 hour battery, Bluetooth) and will be tested alongside continuous movement and oxygenation monitoring. Data will be analyzed to determine whether the combined devices can replicate sleep stage scoring and detect sleep-related events in this pediatric population.

Why it matters

Potential benefit: If successful, this approach could enable easier, less invasive sleep monitoring for children and adolescents and improve access to diagnostic information outside the sleep lab.

How similar studies have gone: Actigraphy has established clinical use for certain pediatric sleep disorders, but combining dry EEG headbands with ring oximeters for pediatric sleep staging is relatively new and less well validated.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Instituto da Criança do Hospital da Clínicas - FMUSP
    São Paulo, São Paulo, Brazil
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.