Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, Taiwan, 23561
NCT Number: NCT06633887
The clinical study aims to develop and validate the TipTraQ system, created by PranaQ, a home sleep test for 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).
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Notify Me20 year–80 year
All sexes
Observational
New Taipei City, Taiwan, 23561
Sleep-disordered breathing is a common disease that affects life function and quality of life, and it also imposes a great burden on the public health system. Obstructive sleep apnea accounts for the largest proportion of sleep-disordered breathing, and because of the oriental facial structure, the prevalence of sleep-disordered breathing is relatively high. The current gold standard for diagnosis OSA is polysomnography (PSG). Although the physiological information collected by PSG is complete and detailed, it requires a considerable amount of manpower and medical resources, and changes in the sleep environment also cause bias in the accuracy of inspection. So far, the tools for simple and accurate screening and diagnosis OSA are relatively limited. In this study, TipTraQ, a wearable device developed by PranaQ, was used to collect photoplethysmography (PPG) of patients during the night of PSG inspection. The reliability and validity analysis was carried out by comparing with the corresponding indicators of PSG, and the feasibility of TipTraQ as a tool for home sleep test (HST).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects from the age of 20 and older that have an indication for an in-lab PSG study.
Exclusion criteria
Time frame: From the start of a single polysomnography study to the end of the recording, 1 night.
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, 1 night.
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, 1 night.
Total sleep time during the polysomnography (PSG)
PranaQ Pte. Ltd.
Industry
Feasibility Evaluation of Sleep Apnea Screening with Photoplethysmography
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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