Performance Evaluation of a Flexible Sensor-Based Intelligent Monitoring Device for Obstructive Sleep Apnea-Hypopnea Syndrome

Objective To evaluate the accuracy of the flexible sensor-based intelligent sleep apnea screening device (TTQ-01) in detecting and diagnosing obstructive sleep apnea hypopnea syndrome (OSAHS) and assessing its severity.

Methods Patients with confirmed or suspected OSAHS who met the inclusion criteria underwent simultaneous monitoring with both the TTQ-01 screening device and polysomnography (PSG). PSG findings served as the reference standard. After monitoring, data were anonymized and paired before analysis. Statistical analyses included descriptive statistics, Cohen's kappa coefficient, and Bland-Altman analysis.

Results For the detection of OSAHS, the TTQ-01 demonstrated an overall accuracy of 97.35% (95% CI: 93.82%-99.10%), a sensitivity of 98.21% (95% CI: 93.82%-99.70%), a specificity of 94.85% (95% CI: 82.67%-98.98%), and a Cohen's kappa coefficient of 0.94 (95% CI: 0.882-0.996), indicating almost perfect agreement with PSG. For the classification of OSAHS severity, the overall agreement rate was 90.07% (95% CI: 85.29%-94.85%), with a sensitivity of 88.39% (95% CI: 82.45%-94.33%), a specificity of 94.87% (95% CI: 82.67%-99.98%), and a Kappa coefficient of 0.825 (95% CI: 0.750-0.900), reflecting strong agreement. Bland-Altman analysis of AHI values measured by TTQ-01 and PSG showed overall unacceptable agreement, with PSG yielding systematically higher values. Subgroup analysis by severity revealed unacceptable agreement in the normal group (with PSG bias elevated), borderline agreement in the mild group, and acceptable agreement in both the moderate and severe groups.

Conclusion The TTQ-01 flexible sensor-based intelligent sleep apnea screening device demonstrated high concordance with PSG in both identifying OSAHS and classifying its severity. In particular, TTQ-01 showed good agreement with PSG among patients with moderate-to-severe OSAHS, suggesting its potential clinical utility as a monitoring and assessment tool in this population. TTQ-01 may serve as a valuable adjunct to support the clinical diagnosis of OSAHS.