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.
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.
Eligibility
Sex
ALL
Min age
3 Years
Max age
18 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Sleep Latency — Immediately after the polysomnography. Time from the beginning of the polysomnographic record until the first epoch of sleep.
Total sleep time — Immediately after the polysomnography. Total time of epochs staged as sleep.
Sleep efficiency — Immediately after the polysomnography. Percentage of sleep in relation to total record/bed time.
Wake after sleep onset — Immediately after the polysomnography. Total time of epochs staged as "wake" after sleep latency.
Latency to REM sleep — Immediately after the polysomnography. Time from sleep latency until the first epoch of REM sleep.
Total time for each sleep stage — Immediately after the polysomnography. Time corresponding to epochs staged as each of the sleep stages (N1, N2, N3 and REM)
Percentage each sleep stage — Immediately after the polysomnography. Percentage corresponding to epochs staged as each of the sleep stages (N1, N2, N3 and REM), in comparison with total sleep time.
Trial sites (1)
Facility
City
Region
Status
Instituto da Criança do Hospital da Clínicas - FMUSP
São Paulo
São Paulo
Recruiting
More SleepUp Tecnologia em Saúde Ltda trials in Brazil
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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