Pediatric Sleep Apnea, Sleep
Conditions
Keywords
Pediatric sleep, Adolescent sleep, EEG
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.
Detailed description
This study aims to evaluate the viability of the combined use of wearable and portable technologies for sleep staging. The results will be compared with polysomnography, in order to achieve clinical and diagnostic validation. Three domains of devices will be used: * Movement sensors: Devices equipped with movement sensors (such as an accelerometer) able to monitor movement over the using period, converting this information in data related to the sleep-wakefulness cycle. In this category, the reference devices are the actimeters/actigraphs (ACT). Its use is recommended by the American Academy of Sleep Medicine to the diagnosis of insomnia and circadian sleep disorders, and should be used for 3 to 14 consecutive days. Other wearable devices, such as smartwatches, are also used with the same purpose, although not validated for clinical use. * Wearable EEG band: EEG is a mandatory feature for type-1 polysomnography and a requirement for regular sleep staging. The project will utilize a wearable EEG band in combination with actigraphy and a ring oximeter to improve the estimation of sleep stages. This study will test wearable EEG bands with the following minimal specifications: dry EEG electrodes (no need for paste, gel, or other conductors), presented as a headband or stripe, a minimal sampling rate of 500Hz, noise, high and low filters, a battery lasting at least 8 hours, a maximum weight of 200g (including the whole device), and support for Bluetooth connection. * Ring oximeter: The project will utilize a ring oximter to record the overnight blood oxygen levels, heart rates, and body movements.
Interventions
DIAGNOSTIC_TESTDiagnostic 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
SleepUp Tecnologia em Saúde Ltda
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Contacts
Primary ContactLeticia Soster, PhD
Outcome results
None listed