Validation of the TipTraQ Wearable Device with AI for Detecting Obstructive Sleep Apnea

What this Trial Is About

Researchers are evaluating the TipTraQ device, a new wearable sleep screening tool developed by PranaQ, designed to detect Sleep Breathing Disorders such as obstructive sleep apnea-hypopnea syndrome OSAHS. The study aims to validate this device by comparing its performance with the traditional polysomnography PSG test, which is the current standard for sleep disorder diagnosis but is complex and requires specialist interpretation. This research seeks to make sleep disorder screening more accessible and easier for patients. Participants will wear the TipTraQ device on their fingertip during an in-lab PSG sleep study at a sleep center. The TipTraQ device uses photoplethysmography and an accelerometer to monitor physiological sleep parameters. Data collected by TipTraQ will be analyzed using an artificial intelligence system on a cloud server. The study plans to enroll 125 subjects who will use the device alongside a mobile app, with the goal of comparing the AI-generated results to expert PSG annotations. During the study, participants will undergo a single PSG study lasting between 4 to 10 hours while simultaneously using the TipTraQ device. Researchers will measure key outcomes including the Oxygen Desaturation Index, Apnea Hypopnea Index, and Total Sleep Time. Participants can withdraw at any time. The studys duration for each participant is limited to the time of the sleep study, with no long-term follow-up specified.

TipTraQ Home Sleep Test Validation Study, VGH