Wearable devices for tracking sleep in children and teens
Evaluation of Wearable Technologies for Sleep Monitoring in Children and Adolescents
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 type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | SleepUp Tecnologia em Saúde Ltda Industry-sponsored |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT06237842 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
São Paulo, São Paulo
- Instituto da Criança do Hospital da Clínicas - FMUSP — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Leticia Soster, PhD — Instituto da Criança do Hospital da Clínicas- FMUSP
- Study coordinator: Leticia Soster, PhD
- Email: sonoinfantilicr@gmail.com
- Phone: +55 11 2661-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.