Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606691
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Wearable Technology in the Detection and Evaluation of Sleep-Related Breathing Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Wearable Technology in the Detection and Evaluation of Sleep-Related Breathing Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReSTech
Brief Summary:
This project is an observational study that aims to evaluate the accuracy of wearable devices in detecting potential sleep-related breathing disorders SRBD in individuals visiting the Sleep-Related Breathing Disorders and Home Ventilation Unit The main goal of the study is to determine if wearable devices like sleep and activity-tracking wristbands and watches can effectively supplement the detection of these disorders
The study will analyze various variables related to sleep quality and quantity Participants will be asked to wear a Xiaomi Mi Band 8 device during an overnight hospital polygraphy test which will be conducted for one day in their usual daily environment Additionally at the beginning of their participation they will need to complete a questionnaire collecting information about sociodemographic variables daily habits routines and their assessment using the Epworth Sleepiness Scale
After completing the polygraphy test and using the Xiaomi device participants will be required to answer another questionnaire addressing aspects related to their sleep quality and habits during this period
The study will analyze various variables related to sleep quality and quantity Participants will be asked to wear a Xiaomi Mi Band 8 device during an overnight hospital polygraphy test which will be conducted for one day in their usual daily environment Additionally at the beginning of their participation they will need to complete a questionnaire collecting information about sociodemographic variables daily habits routines and their assessment using the Epworth Sleepiness Scale
After completing the polygraphy test and using the Xiaomi device participants will be required to answer another questionnaire addressing aspects related to their sleep quality and habits during this period
Detailed Description:
In recent years sleep disorders have gained importance due to their high prevalence and impact on daily life affecting people39s ability to perform daily tasks and reducing quality of life These disorders include difficulties falling asleep respiratory interruptions and poor sleep quality with sleep-related breathing disorders SRBD such as obstructive sleep apnea OSA being particularly significant OSA which involves repeated airway obstructions during sleep is especially common in older adults individuals with obesity and men but it remains frequently underdiagnosed
SRBD not only disrupts sleep but also increases the risk of chronic conditions like diabetes hypertension and strokes while creating an economic burden due to higher demand for medical resources Their effects on physical and mental health lead to fatigue reduced productivity workplace accidents and even disability highlighting the need for more efficient diagnostic and management tools
While polysomnography PSG is the gold standard for diagnosing sleep disorders its high cost and invasive nature limit its accessibility Wearable devices such as wristbands and watches offer a more accessible and non-invasive alternative providing real-time data on sleep heart rate and activity Though promising these devices still require further research to confirm their accuracy in detecting SRBD This project aims to evaluate the effectiveness of wearables as complementary tools in diagnosing and managing these disorders Specifically it has the following specific objectives 1 To assess the accuracy specificity and sensitivity of wearable devices such as wristbands and watches in measuring blood oxygen saturation heart rate and activity compared to nocturnal polygraphy 2 To analyze the effectiveness of these devices in identifying individuals with potential sleep-related breathing disorders SRBD using unsupervised learning techniques 3 To evaluate the impact and performance of an Artificial Intelligence model for detecting and classifying potential SRBD
SRBD not only disrupts sleep but also increases the risk of chronic conditions like diabetes hypertension and strokes while creating an economic burden due to higher demand for medical resources Their effects on physical and mental health lead to fatigue reduced productivity workplace accidents and even disability highlighting the need for more efficient diagnostic and management tools
While polysomnography PSG is the gold standard for diagnosing sleep disorders its high cost and invasive nature limit its accessibility Wearable devices such as wristbands and watches offer a more accessible and non-invasive alternative providing real-time data on sleep heart rate and activity Though promising these devices still require further research to confirm their accuracy in detecting SRBD This project aims to evaluate the effectiveness of wearables as complementary tools in diagnosing and managing these disorders Specifically it has the following specific objectives 1 To assess the accuracy specificity and sensitivity of wearable devices such as wristbands and watches in measuring blood oxygen saturation heart rate and activity compared to nocturnal polygraphy 2 To analyze the effectiveness of these devices in identifying individuals with potential sleep-related breathing disorders SRBD using unsupervised learning techniques 3 To evaluate the impact and performance of an Artificial Intelligence model for detecting and classifying potential SRBD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None