Clinical trial NCT06237842: Wearable Technologies for Sleep in Children and Adolescents
Official title: Evaluation of Wearable Technologies for Sleep Monitoring in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sleep
Pediatric Sleep Apnea
Lead sponsor: SleepUp Tecnologia em Saúde Ltda
Sponsor class: INDUSTRY
First posted: 2024-02-02
Enrollment: 48
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children/adolescents who come to the Sleep Laboratory of the Children's Institute of the University of São Paulo for a polysomnography test.

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, achieving a minimum of 85% sleep efficiency on the night of the test.

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.

Eligibility 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:

* Individuals with sleep efficiency lower than 85% on the night in question.

Primary outcomes:
measure: Sleep Latency
timeFrame: Immediately after the polysomnography.
measure: Total sleep time
timeFrame: Immediately after the polysomnography.
measure: Sleep efficiency
timeFrame: Immediately after the polysomnography.
measure: Wake after sleep onset
timeFrame: Immediately after the polysomnography.
measure: Latency to REM sleep
timeFrame: Immediately after the polysomnography.
measure: Total time for each sleep stage
timeFrame: Immediately after the polysomnography.
measure: Percentage each sleep stage
timeFrame: Immediately after the polysomnography.
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto da Criança do Hospital da Clínicas - FMUSP
Study officials:
affiliation: Instituto da Criança do Hospital da Clínicas- FMUSP
name: Leticia Soster, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto da Criança do Hospital da Clínicas- FMUSP
name: Anna Monazzi, PhD
role: STUDY_DIRECTOR
References: