人工智能增强型家庭睡眠呼吸暂停检测设备研究（AISAP 研究）。

Artificial intelligence augmented home sleep apnea testing device study (AISAP study).

机构信息

Division of Pulmonary, Critical Care and Sleep Medicine, West Virginia University, Morgantown, WV, United States of America.

Department of Respiratory Care, Ruby Memorial Hospital, Morgantown, WV, United States of America.

出版信息

PLoS One. 2024 May 17;19(5):e0303076. doi: 10.1371/journal.pone.0303076. eCollection 2024.

DOI:10.1371/journal.pone.0303076

PMID:38758825

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11101079/

Abstract

STUDY OBJECTIVE

This study aimed to prospectively validate the performance of an artificially augmented home sleep apnea testing device (WVU-device) and its patented technology.

METHODOLOGY

The WVU-device, utilizing patent pending (US 20210001122A) technology and an algorithm derived from cardio-pulmonary physiological parameters, comorbidities, and anthropological information was prospectively compared with a commercially available and Center for Medicare and Medicaid Services (CMS) approved home sleep apnea testing (HSAT) device. The WVU-device and the HSAT device were applied on separate hands of the patient during a single night study. The oxygen desaturation index (ODI) obtained from the WVU-device was compared to the respiratory event index (REI) derived from the HSAT device.

RESULTS

A total of 78 consecutive patients were included in the prospective study. Of the 78 patients, 38 (48%) were women and 9 (12%) had a Fitzpatrick score of 3 or higher. The ODI obtained from the WVU-device corelated well with the HSAT device, and no significant bias was observed in the Bland-Altman curve. The accuracy for ODI > = 5 and REI > = 5 was 87%, for ODI> = 15 and REI > = 15 was 89% and for ODI> = 30 and REI of > = 30 was 95%. The sensitivity and specificity for these ODI /REI cut-offs were 0.92 and 0.78, 0.91 and 0.86, and 0.94 and 0.95, respectively.

CONCLUSION

The WVU-device demonstrated good accuracy in predicting REI when compared to an approved HSAT device, even in patients with darker skin tones.

摘要

研究目的

本研究旨在前瞻性验证一种人工增强的家庭睡眠呼吸暂停测试设备（WVU 设备）及其专利技术的性能。

方法

WVU 设备利用专利申请中（美国 20210001122A）的技术和一种源自心肺生理参数、合并症和人类学信息的算法，与一种商业可用且获得美国医疗保险和医疗补助服务中心（CMS）批准的家庭睡眠呼吸暂停测试（HSAT）设备进行前瞻性比较。在单个夜间研究中，WVU 设备和 HSAT 设备分别应用于患者的一只手上。从 WVU 设备获得的氧减指数（ODI）与从 HSAT 设备获得的呼吸事件指数（REI）进行比较。

结果

共有 78 例连续患者纳入前瞻性研究。78 例患者中，38 例（48%）为女性，9 例（12%）为 Fitzpatrick 评分 3 或更高。从 WVU 设备获得的 ODI 与 HSAT 设备相关性良好，Bland-Altman 曲线未见明显偏倚。ODI> = 5 和 REI> = 5 的准确率为 87%，ODI> = 15 和 REI> = 15 的准确率为 89%，ODI> = 30 和 REI> = 30 的准确率为 95%。这些 ODI/REI 截止值的灵敏度和特异性分别为 0.92 和 0.78、0.91 和 0.86、0.94 和 0.95。