Röcken Jonathan, Darie Andrei M, Grize Leticia, Dexter Claire Ellen, Herrmann Matthias J, Jahn Kathleen, Strobel Werner, Tamm Michael, Stolz Daiana
Clinic of Respiratory Medicine and Pulmonary Cell Research, University Hospital Basel, Basel, Switzerland.
Clinic of Respiratory Medicine, University of Freiburg, Freiburg, Germany.
BMC Pulm Med. 2025 Apr 3;25(1):150. doi: 10.1186/s12890-025-03618-9.
Inpatient polysomnography (PSG) is the gold standard for the diagnosis of obstructive sleep apnoea (OSA), however, both complexity and costs limit the availability of this examination. Home sleep apnoea testing devices are a diagnostic alternative in patients with increased risk of OSA. We evaluated the diagnostic performance of a Doppler radar technology based, contactless sleep apnoea testing device (CSATD) in a cohort of patients with a clinically increased risk of OSA.
Monocentric prospective study. Sleep monitoring with the CSATD SleepizOne + without pulse oximetry (Sleepiz AG, Switzerland) was performed simultaneously with elective inpatient PSG. PSG was analysed blinded to the CSATD results and according to AASM 2012 criteria by certified sleep physicians. The CSATD data were analysed automatically and independently by a dedicated software.
A total of 102 patients, 60.8% male, with an average age of 55 ± 15 years and body mass index of 30 ± 6 kg/m2 were included in the analysis. The sensitivity and specificity of the CSATD for a PSG apnoea-hypopnoea-index (AHI) of ≥ 5/h were 0.89 (95%CI: 0.83-0.96) and 0.88 (95%CI: 0.73-1.0). The negative and positive predictive values were 0.62 (95%CI: 0.42-0.82) and 0.97 (95%CI: 0.94-1.0). The diagnostic agreement for the diagnosis of OSA (defined as PSG AHI ≥ 5/h) was 89.8% and 100% using a CSATD AHI threshold of ≥ 5/h (n = 79/88) and ≥ 15/h (n = 61/61). However, the concordance was poor in the classification of OSA severity, with 50% (13/26) concordance for mild, 38% (10/26) for moderate, and 76% (25/33) for severe OSA respectively.
CSATD accurately identifies patients with OSA, particularly using an AHI threshold of ≥ 15/h. However, it performs subpar in disease severity stratification.
This trial was registered on the International Clinical Trials Registry Platform, ISRCTN45778591.
住院多导睡眠图（PSG）是诊断阻塞性睡眠呼吸暂停（OSA）的金标准，然而，其复杂性和成本限制了该检查的可及性。家庭睡眠呼吸暂停检测设备是OSA风险增加患者的一种诊断替代方法。我们评估了一种基于多普勒雷达技术的非接触式睡眠呼吸暂停检测设备（CSATD）在一组临床OSA风险增加患者中的诊断性能。
单中心前瞻性研究。使用CSATD SleepizOne +（无脉搏血氧饱和度监测，瑞士Sleepiz AG公司）进行睡眠监测，同时进行择期住院PSG检查。PSG由经过认证的睡眠医生在对CSATD结果不知情的情况下，按照美国睡眠医学会2012年标准进行分析。CSATD数据由专用软件自动独立分析。
共纳入102例患者，男性占60.8%，平均年龄55±15岁，体重指数30±6kg/m²。对于PSG呼吸暂停低通气指数（AHI）≥5次/小时，CSATD的敏感性和特异性分别为0.89（95%CI：0.83 - 0.96）和0.88（95%CI：0.73 - 1.0）。阴性和阳性预测值分别为0.62（95%CI：0.42 - 0.82）和0.97（95%CI：0.94 - 1.0）。使用CSATD AHI阈值≥5次/小时（n = 79/88）和≥15次/小时（n = 61/61）时，OSA诊断（定义为PSG AHI≥5次/小时）的诊断一致性分别为89.8%和100%。然而，在OSA严重程度分类方面一致性较差，轻度OSA的一致性为50%（13/26），中度为38%（10/26），重度为76%（25/33）。
CSATD能准确识别OSA患者，尤其是使用AHI阈值≥15次/小时时。然而，其在疾病严重程度分层方面表现欠佳。
本试验在国际临床试验注册平台注册，注册号为ISRCTN45778591。
