Ignite Creation Date:
2024-07-17 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474390
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-13
Brief Title:
TipTraQ Home Sleep Test Validation Study VGH
Sponsor:
PranaQ Pte Ltd
Organization:
PranaQ Pte Ltd
Study Overview
Official Title:
Validation of a Medical-grade Wearable Device with Interpretable Artificial Intelligence System for the Obstructive Sleep Apnea-hypopnea Syndrome OSAHS Evaluation
Status:
RECRUITING
Status Verified Date:
2024-10
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:
A validation study has been designed to assess the performance of a home sleep test device TipTraQ for screening sleep apnea The study involves participants wearing the TipTraQ device on their fingertip during a traditional sleep test known as polysomnography PSG conducted in a sleep center The performance of the device will then be evaluated by comparing the results from the TipTraQ system with those from the traditional sleep test
Detailed Description:
This clinical study is designed to validate TipTraQ a new sleep screening device developed by PranaQ for the detection of Sleep Breathing Disorders SBD including obstructive sleep apnea-hypopnea syndrome OSAHS Given the high prevalence of undiagnosed OSAHS and the cumbersome nature of traditional polysomnography PSG - which involves multiple sensors and specialist interpretation - there is a pressing need for more accessible screening tools TipTraQ aims to meet this need through a wearable device that utilizes photoplethysmography PPG and an accelerometer to monitor essential physiological parameters during sleep This information is then analyzed by an interpretable artificial intelligence AI system to estimate key indicators of sleep health such as SpO2 total sleep time TST oxygen desaturation index ODI and apnea-hypopnea index AHI
The study is open-label and non-randomized planning to recruit 125 subjects Participants will use the TipTraQ device alongside a companion mobile app with data analysis supported by AI technology hosted on a cloud server The primary goal is to assess the accuracy of the TipTraQ system by comparing its output against the gold standard PSG annotations made by sleep experts
This initiative represents a significant step towards simplifying and democratizing the screening process for sleep disorders potentially enabling early detection and treatment for a larger segment of the population thus mitigating personal health risks and broader societal impacts of undiagnosed SBD
The study is open-label and non-randomized planning to recruit 125 subjects Participants will use the TipTraQ device alongside a companion mobile app with data analysis supported by AI technology hosted on a cloud server The primary goal is to assess the accuracy of the TipTraQ system by comparing its output against the gold standard PSG annotations made by sleep experts
This initiative represents a significant step towards simplifying and democratizing the screening process for sleep disorders potentially enabling early detection and treatment for a larger segment of the population thus mitigating personal health risks and broader societal impacts of undiagnosed SBD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None