Validation of a fingertip home sleep apnea testing system using deep learning AI and a temporal event localization analysis.

STUDY OBJECTIVES

This paper validates TipTraQ, a compact home sleep apnea testing (HSAT) system. TipTraQ comprises a fingertip-worn device, a mobile application, and a cloud-based deep learning artificial intelligence (AI) system. The device utilizes photoplethysmography (red, infrared, and green channels) and accelerometer sensors to assess sleep apnea by the AI system.

METHODS

We prospectively enrolled 240 participants suspected of obstructive sleep apnea (OSA) at a tertiary medical center for internal validation and 112 participants independently at another center for external validation. All participants underwent simultaneous polysomnography and TipTraQ HSAT. We compared TipTraQ-derived total sleep time (TQ-TST) and TipTraQ-derived Respiratory Events Index (TQ-REI) with expert-determined TST and apnea-hypopnea index (AHI), based on AASM standards with the 1B hypopnea rule. Temporal event localization analysis for respiratory event prediction was conducted at both event and hourly levels.

RESULTS

In the external validation, the Spearman correlation coefficients for TQ-TST vs. TST and TQ-REI vs. AHI were 0.81 and 0.95, respectively. The root mean square error were 0.53 hours for TQ-TST vs. TST and 7.53 events/h for TQ-REI vs. AHI. For apnea/hypopnea prediction with a 10-second grace period, the true positive, false positive, and false negative rates in temporal event localization analysis were 0.76, 0.24, and 0.23, respectively. The four-way OSA severity classification achieved a Cohen's kappa of 0.7.

CONCLUSIONS

TQ-TST and TQ-REI predict TST and AHI with comparable performance to existing devices of the same type, and respiratory event prediction is validated through temporal event localization analysis.

CLINICAL TRIALS

Development of TipTraQ Home Sleep Test, https://clinicaltrials.gov/study/NCT06474351?term=NCT06474351&rank=1, NCT06474351TipTraQ Home Sleep Test Study, SHH, https://clinicaltrials.gov/study/NCT06633887?term=NCT06633887&rank=1, NCT06633887.