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柔性传感智能监测仪对阻塞性睡眠呼吸暂停综合征监测的效果评价

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

    摘要
  • 摘要:
    目的 评估柔性传感智能睡眠呼吸初筛仪（TTQ-01）检测诊断阻塞性睡眠呼吸暂停综合征（OSAHS）及OSAHS严重程度的准确性。
    方法 筛选符合纳入标准的OSAHS患者或疑似患者同步开展睡眠呼吸初筛仪（TTQ-01）、PSG双仪器监测，以PSG检测结果为金标准，监测结束匿名化配对阻断处理后，采用描述性统计、Cohen's Kappa检验等、Bland–Altman分析等进行分析。
    结果 睡眠呼吸初筛仪（TTQ-01）与PSG监测判断的OSAHS的准确率为97.35%（95%可信区间（CI）93.82%～99.10%），灵敏度为98.21%（95%CI 93.82%～99.70%），特异度为94.85%（95%CI 82.67%～98.98%），κ系数为0.940（95%CI 0.882～0.996）；TTQ-01与PSG监测判断的OSAHS程度一致率为90.07%（95%CI 85.29%～94.85%），灵敏度为88.39%（95%CI 82.45%～94.33%），特异度为94.87%（95%CI 82.67%～99.98%），κ系数为0.83（95%CI 0.75～0.90）。TTQ-01和PSG测量AHI值Bland-Altman分析总体一致性不可接受，PSG偏高；按照不同严重程度亚组分析，正常组的一致性不可接受，PSG偏高，轻度组一致性为临界，中度和重度组为一致。
    结论 柔性传感智能睡眠呼吸初筛仪（TTQ-01）与PSG监测在判断是否存在OSAHS和判断OSAHS程度上一致性高。TTQ-01与PSG在中、重度OSAHS患者中具有良好的一致性，具备作为该类人群病情监测与评估工具的潜在临床应用价值，可为OSAHS的辅助诊断提供参考。

     

    Abstract:
    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.

     

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