Wearable Technologies for Sleep in Children and Adolescents

Sleep Clinical Trial

Official title:

Evaluation of Wearable Technologies for Sleep Monitoring in Children and Adolescents

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06237842
• Other study ID #: SleepUp_#03
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2024
• Source: SleepUp Tecnologia em Saúde Ltda
• Contact: Leticia Soster, PhD
• Phone: +55 11 2661-8500
• Email: let.azevedo[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: March 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pediatric Sleep Apnea
• Sleep
• Sleep Apnea Syndromes

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Brazil	SleepUp Tecnologia em Saúde LTDA	São Caetano Do Sul	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
SleepUp Tecnologia em Saúde Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Latency	Time from the beginning of the polysomnographic record until the first epoch of sleep.	Immediately after the polysomnography.
Primary	Total sleep time	Total time of epochs staged as sleep.	Immediately after the polysomnography.
Primary	Sleep efficiency	Percentage of sleep in relation to total record/bed time.	Immediately after the polysomnography.
Primary	Wake after sleep onset	Total time of epochs staged as "wake" after sleep latency.	Immediately after the polysomnography.
Primary	Latency to REM sleep	Time from sleep latency until the first epoch of REM sleep.	Immediately after the polysomnography.
Primary	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.
Primary	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.