NCT06633887

TipTraQ Home Sleep Test Study, SHH

Feasibility Evaluation of Sleep Apnea Screening with Photoplethysmography

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 112 (actual)
• Sponsor: PranaQ Pte. Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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).

Conditions

• Obstructive Sleep Apnea

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-02-28
• Completion: 2024-03-27
• First posted: 2024-10-09
• Last updated: 2024-10-18

Locations

1 site across 1 country: Taiwan