Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237842
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-01-23
Brief Title:
Wearable Technologies for Sleep in Children and Adolescents
Sponsor:
SleepUp Tecnologia em Saúde Ltda
Organization:
SleepUp Tecnologia em Saúde Ltda
Study Overview
Official Title:
Evaluation of Wearable Technologies for Sleep Monitoring in Children and Adolescents
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Childrens 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
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 Childrens 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 actimetersactigraphs 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
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 actimetersactigraphs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None