Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-03-01 @ 4:45 PM
Study NCT ID:
NCT06474351
Status:
COMPLETED
Last Update Posted:
2024-10-22
First Post:
2024-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developement of TipTraQ Home Sleep Test
Sponsor:
PranaQ Pte. Ltd.
Organization:
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:
False
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?:
False
Is an FDA AA801 Violation?: