Sleep medicine · 2026
External validation of a fingertip wearable device for obstructive sleep apnea diagnosis and split-night tracking of CPAP treatment response.
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Chen Ke-Wei, Husain Aatif M, Rapoport David M, Wu Hau-Tieng
Аннотация
STUDY OBJECTIVES: To externally validate a novel Type IV fingertip wearable device, TipTraQ, against polysomnography (PSG) for diagnosing obstructive sleep apnea (OSA) in the western-country population with both AASM AHI1A(3%) and AHI1B(4%) labeling rules. Furthermore, evaluate its ability to dynamically track positive airway pressure (PAP) treatment effectiveness using split-night titration as surrogate with short-term apnea-hypopnea index (AHI) and TipTraQ-derived Respiratory Events Index (TQ-REI) sequences.
METHODS: In a prospective study at the Duke Sleep Disorders Center, 198 participants were enrolled, including a diagnostic validation cohort (n = 147) and a split-night titration cohort (n = 29). Short-term AHI and TQ-REI sequences were calculated using a 15-min moving window updated every 5 min to capture respiratory event dynamics. Agreement between TipTraQ and PSG was evaluated using standard performance metrics.
RESULTS: In the diagnostic cohort, TipTraQ correlated strongly with PSG for total sleep time (TST; PCC = 0.786) and REM duration (PCC = 0.655). Bland-Altman analysis revealed mean biases of -9.50 min for TST and -9.46 min for REM. Epoch-by-epoch sleep staging (Wake, REM, Non-REM) yielded a Cohen's Kappa of 0.567, with highest sensitivity in non-REM sleep (0.824). TQ-REI correlated highly with AHI under AASM scoring rules (PCC = 0.879 for 1A; 0.910 for 1B). In the titration cohort, TipTraQ maintained consistent performance. Analysis of short-term AHI and TQ-REI sequences demonstrated the device's ability to track respiratory event dynamics, yielding a median PCC of 0.882 (1A) and 0.872 (1B).
CONCLUSION: TipTraQ shows strong agreement with PSG for respiratory metrics and moderate agreement with PSG for sleep metrics, and captures temporal dynamics of sleep-disordered breathing events.
METHODS: In a prospective study at the Duke Sleep Disorders Center, 198 participants were enrolled, including a diagnostic validation cohort (n = 147) and a split-night titration cohort (n = 29). Short-term AHI and TQ-REI sequences were calculated using a 15-min moving window updated every 5 min to capture respiratory event dynamics. Agreement between TipTraQ and PSG was evaluated using standard performance metrics.
RESULTS: In the diagnostic cohort, TipTraQ correlated strongly with PSG for total sleep time (TST; PCC = 0.786) and REM duration (PCC = 0.655). Bland-Altman analysis revealed mean biases of -9.50 min for TST and -9.46 min for REM. Epoch-by-epoch sleep staging (Wake, REM, Non-REM) yielded a Cohen's Kappa of 0.567, with highest sensitivity in non-REM sleep (0.824). TQ-REI correlated highly with AHI under AASM scoring rules (PCC = 0.879 for 1A; 0.910 for 1B). In the titration cohort, TipTraQ maintained consistent performance. Analysis of short-term AHI and TQ-REI sequences demonstrated the device's ability to track respiratory event dynamics, yielding a median PCC of 0.882 (1A) and 0.872 (1B).
CONCLUSION: TipTraQ shows strong agreement with PSG for respiratory metrics and moderate agreement with PSG for sleep metrics, and captures temporal dynamics of sleep-disordered breathing events.