目的:评估无线双传感器系统(ANNEsleep)与参考标准多导睡眠图(PSG)在诊断中度和重度阻塞性睡眠呼吸暂停(OSA)中的每个患者的诊断性能,其敏感性和特异性的最低预设阈值为80%。
方法:进行了一项多中心临床试验,以评估ANNE睡眠与PSG,以诊断22岁或以上个体的中度和重度OSA。对于每种测试方法,呼吸暂停低通气指数(AHI)由3名对其他系统不知情的注册睡眠技术人员进行手动评分和平均。睡眠医学医师裁定平均变异>15%。
结果:总共有225名参与者(平均年龄53岁,范围22-88年),PSG诊断为中度或重度OSA(AHI≥15事件/h)的参与者中有30%(n=68),而ANNE睡眠诊断为29%(n=65)(P=0.55)。ANNE睡眠的敏感性和特异性分别为90%(95%置信区间:80-96%)和98%(95%置信区间:94-99%),分别。在最终AHI方面显示出强相关性(r=.93),平均AHI偏差为0.5(95%的一致性限制:-12.8至11.8)。大多数用户注意到在家庭环境中使用ANNE睡眠的舒适性。没有注意到不良事件。
结论:使用PSG作为黄金标准,ANNE睡眠显示出诊断中度或重度OSA的高灵敏度和特异性。
背景:注册:ClinicalTrials.gov;名称:ANNE™One系统诊断阻塞性睡眠呼吸暂停的比较研究;URL:https://clinicaltrials.gov/ct2/show/NCT04643782;标识符:NCT04643782。
背景:戴维斯C,LeeJY,沃尔特·J等人。单臂,开放标签,多中心,ANNE睡眠系统与多导睡眠图诊断阻塞性睡眠呼吸暂停的比较研究。JClinSleepMed.2022年;18(12):2703–2712。
Evaluate per-patient diagnostic performance of a wireless dual-sensor system (ANNE sleep) compared with reference standard polysomnography (PSG) for the diagnosis of moderate and severe obstructive sleep apnea (OSA) with a minimum prespecified threshold of 80% for both sensitivity and specificity.
A multicenter clinical
trial was conducted to evaluate ANNE sleep vs PSG to diagnose moderate and severe OSA in individuals 22 years or older. For each testing approach, apnea-hypopnea index (AHI) was manually scored and averaged by 3 registered sleep technologists blinded to the other system. Average variations > 15% were adjudicated by a sleep medicine physician.
In a total of n = 225 participants (mean age 53 years, range 22-88 years), PSG diagnosed 30% (n = 68) of participants with moderate or severe OSA (AHI ≥ 15 events/h) compared to 29% (n = 65) diagnosed by ANNE sleep (P = .55). The sensitivity and specificity for ANNE sleep were 90% (95% confidence interval: 80-96%) and 98% (95% confidence interval: 94-99%), respectively. Strong correlation was shown in terms of final AHI (r = .93), with an average AHI bias of 0.5 (95% limits of agreement: -12.8 to 11.8). The majority of users noted comfort with using the ANNE sleep in the home setting. No adverse events were noted.
Using PSG as the gold standard, ANNE sleep demonstrated high sensitivity and specificity for the diagnosis of moderate or severe OSA.
Registry: ClinicalTrials.gov; Name: Comparative
Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT04643782; Identifier: NCT04643782.
Davies C, Lee JY, Walter J et al. A single-arm, open-label, multicenter, and comparative
study of the ANNE sleep system vs polysomnography to diagnose obstructive sleep apnea. J Clin Sleep Med. 2022;18(12):2703-2712.