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.
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.
Study Type
OBSERVATIONAL
Enrollment
125
Taipei Veterans General Hospital
Taipei, Taipei, Taiwan
RECRUITINGOxygen Desaturation Index(ODI)
Average desaturation episodes with a decrease in the oxygen saturation of ≥4% or 3% per hour
Time frame: From the start of a single polysomnography study to the end of the recording. Time range from 4hour up to 10 hour.
Apnea Hypopnea Index(AHI)
The combined average number of apneas and hypopneas that occur per hour of sleep
Time frame: From the start of a single polysomnography study to the end of the recording. Time range from 4hour up to 10 hour.
Total Sleep Time(TST)
Total sleep time during the polysomnography (PSG)
Time frame: From the start of a single polysomnography study to the end of the recording. Time range from 4hour up to 10 hour.
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