An observational study in Obstructive Sleep Apnea, sponsored by PranaQ Pte. Ltd.. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by PranaQ Pte. Ltd. · Observational
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.
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.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 240 is above the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →PranaQ Pte. Ltd. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Health or people who has indication to conduct polysomnography (PSG).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects from the age of 20 and older that have an indication for an in-lab PSG study. The subject should be able to understand the study and sign the informed consent before being enrolled in the study. During the study period, the subject can withdraw from the study any time.
Exclusion Criteria:
Subjects with the following medical conditions will be excluded from this study:
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. Usually range from 4 to 10 hours
Oxygen 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. Usually range from 4 to 10 hours
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. Usually range from 4 to 10 hours
Ran from Jun 2023 to primary completion in Dec 2023, 6 months.
Of 35 industry-sponsored observational studies under Sleep Apnea, Obstructive, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 93. This study's 6 months is below that.
Counting every sponsor, half of 294 studies reached it within 30 months; a quarter within 15 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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PranaQ Pte. Ltd.