Wearable Technologies for Sleep in Children and Adolescents
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-18
SponsorSleepUp Tecnologia em Saúde Ltda
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None.
Trial population
Children/adolescents who come to the Sleep Laboratory of the Children's Institute of the University of São Paulo for a polysomnography test.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Diagnostic Test: EEG headband+Ring oximeter (RO)+Actigraphy (ACT)
Diagnostic testCombination of ACT+RO+EEG. This is not an intervention, but rather a combination of devices to be tested regarding its diagnostic validity.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Healthy participants1 intervention
Group B: Participants with sleep disorders1 intervention
Trial outcomes
Primary outcomes
1
Sleep Latency
Time from the beginning of the polysomnographic record until the first epoch of sleep.
Time frame
Immediately after the polysomnography.2
Total sleep time
Total time of epochs staged as sleep.
Time frame
Immediately after the polysomnography.3
Sleep efficiency
Percentage of sleep in relation to total record/bed time.
Time frame
Immediately after the polysomnography.4
Wake after sleep onset
Total time of epochs staged as "wake" after sleep latency.
Time frame
Immediately after the polysomnography.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov