Ignite Creation Date:
2024-07-17 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474351
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2024-06-19
Brief Title:
Developement of TipTraQ Home Sleep Test
Sponsor:
PranaQ Pte Ltd
Organization:
PranaQ Pte Ltd
Study Overview
Official Title:
Development and Fine-tuning of a Medical-grade Wearable Device with Interpretable Artificial Intelligence System for the Obstructive Sleep Apnea-hypopnea Syndrome OSAHS Screening
Status:
COMPLETED
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:
The clinical study aims to develop and fine-tune the TipTraQ system created by PranaQ for home sleep apnea screening The system comprises a wearable device and a cloud-based AI for estimating Total Sleep Time TST and Apnea-Hypopnea Index AHI This open-label non-randomized study will recruit 240 subjects aged 20 and older from the Veteran General Hospital Taipei
Detailed Description:
Sleep Breathing Disorders SBD is a common disorder in the population However a lot of patients are not aware of this disease and do not receive proper treatment which not only impacts their personal health but also causes public disasters Thus a screening tool to find those patients becomes a critical point-of-care issue To achieve this goal a wearable device that is suitable for the screening is needed The goal of this study is developing and fine-tuning a new sleep screening platform TipTraQ developed by PranaQ TipTraQ is composed of a wearable device designed as a convenient screening device based on the photoplethysmography PPG technique and an interpretable artificial intelligent AI system that takes the PPG signal recorded by the wearable device as input and outputs and outputs estimated total sleep time TST and apnea-hypopnea index AHI
The study is open-label and non-randomized planning to recruit 240 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 TipTraQ device will be worn over fingertip The primary goal is to assess the robustness of the TipTraQ system and fine-tuned the algorithm by comparing its output against the gold standard PSG annotations made by sleep experts
The study is open-label and non-randomized planning to recruit 240 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 TipTraQ device will be worn over fingertip The primary goal is to assess the robustness of the TipTraQ system and fine-tuned the algorithm by comparing its output against the gold standard PSG annotations made by sleep experts
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