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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy participants | Participants from 3 to 18 years old, from both genders and with no sleep disorders |
| |
| Participants with sleep disorders | Participantes with one sleep disorder or complaint. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Test: EEG headband+Ring oximeter (RO)+Actigraphy (ACT) | Diagnostic Test | Combination of ACT+RO+EEG. This is not an intervention, but rather a combination of devices to be tested regarding its diagnostic validity. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Latency | Time from the beginning of the polysomnographic record until the first epoch of sleep. | Immediately after the polysomnography. |
| Total sleep time | Total time of epochs staged as sleep. | Immediately after the polysomnography. |
| Sleep efficiency | Percentage of sleep in relation to total record/bed time. | Immediately after the polysomnography. |
| Wake after sleep onset | Total time of epochs staged as "wake" after sleep latency. | Immediately after the polysomnography. |
| Latency to REM sleep | Time from sleep latency until the first epoch of REM sleep. | Immediately after the polysomnography. |
| Total time for each sleep stage | Time corresponding to epochs staged as each of the sleep stages (N1, N2, N3 and REM) | Immediately after the polysomnography. |
| Percentage each sleep stage | Percentage corresponding to epochs staged as each of the sleep stages (N1, N2, N3 and REM), in comparison with total sleep time. | Immediately after the polysomnography. |
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Inclusion Criteria:
Exclusion Criteria:
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Children/adolescents who come to the Sleep Laboratory of the Children's Institute of the University of São Paulo for a polysomnography test.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leticia Soster, PhD | Contact | +55 11 2661-8500 | sonoinfantilicr@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Leticia Soster, PhD | Instituto da Criança do Hospital da Clínicas- FMUSP | Principal Investigator |
| Anna Monazzi, PhD | Instituto da Criança do Hospital da Clínicas- FMUSP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto da Criança do Hospital da Clínicas - FMUSP | Recruiting | São Paulo | São Paulo | 05403-000 | Brazil |
The dissemination of Individual Participant Data (IPD) from this study is strictly limited by restrictions on the release of intellectual property, concerns regarding participant privacy and confidentiality, and the absence of explicit consent for extensive data sharing. However, upon reasonable request and subject to approval by the study's principal investigator, anonymized datasets may be provided to qualified researchers. It is imperative that requests include a thorough research proposal and a rationale that substantiates the need for the resources in question.
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