用于检测阻塞性睡眠呼吸暂停的NOX T3(TM)便携式监测仪的初步验证研究。
A pilot validation study for the NOX T3(TM) portable monitor for the detection of OSA.
作者信息
Cairns Alyssa, Wickwire Emerson, Schaefer Edward, Nyanjom David
机构信息
SleepMed, Inc., 700 Gervais St. Suite 200, Columbia, SC, 29201, USA,
出版信息
Sleep Breath. 2014 Sep;18(3):609-14. doi: 10.1007/s11325-013-0924-2. Epub 2014 Jan 19.
PURPOSE
The aim of the current pilot study is to compare the diagnostic accuracy of the NOX T3(TM) (T3) portable sleep monitor (PM) to that of simultaneously recorded in-lab polysomnogram (PSG).
METHODS
A total of 40 participants were recruited following face-to-face evaluation at a sleep disorders clinic. Each participant wore both PSG and PM equipment simultaneously during their in-lab PSG. PSG records were manually scored using the American Academy of Sleep Medicine (AASM) criteria, and PM records were double-scored using the device's autoscore algorithm as well as manual scoring.
RESULTS
The final sample consisted of 32 participants (56% male, 50% black) with a mean ESS, BMI, and apnea-hypopnea index (AHI) of 10.4, 32.8, and 16.3, respectively. Three participants (7.5%) were excluded for poor PM signal quality. Mean AHI derived from the T3's autoscore algorithm was similar to that from manual scoring (19.6 ± 18.9 vs. 18.6 ± 19.1, respectively). Autoscore-derived T3 AHI and PSG-derived AHI were strongly related (r = .93). The T3 (autoscored AHI) demonstrated a high degree of sensitivity for the presence of obstructive sleep apnea syndrome (OSA; 100%) and acceptable specificity for the exclusion of OSA using an AHI cutoff of ≥5 events/h (70%). The unit (autoscored) had a high degree of both sensitivity (92%) and specificity (85%) when the presence of OSA was defined more conservatively (AHI > 15 events/h). For OSA defined as an AHI of ≥5, the T3 (autoscored) correctly identified 88% of positive cases and 100% of negative cases.
CONCLUSIONS
In this small, clinic-based sample, the T3 demonstrated very good measurement agreement compared to PSG and a high degree of sensitivity for detecting even mild OSA. False positives appeared to be due to respiratory effort-related arousals (RERAs) being autoscored as obstructive apneas and may be due to inherent discrepancy in flow measurement sensitivity between PSG and portable monitors.
目的
本初步研究旨在比较NOX T3(TM)(T3)便携式睡眠监测仪(PM)与同时记录的实验室多导睡眠图(PSG)的诊断准确性。
方法
在睡眠障碍诊所进行面对面评估后,共招募了40名参与者。每位参与者在进行实验室PSG检查时同时佩戴PSG和PM设备。PSG记录根据美国睡眠医学学会(AASM)标准进行人工评分,PM记录使用设备的自动评分算法以及人工评分进行双重评分。
结果
最终样本包括32名参与者(56%为男性,50%为黑人),平均Epworth嗜睡量表(ESS)、体重指数(BMI)和呼吸暂停低通气指数(AHI)分别为10.4、32.8和16.3。3名参与者(7.5%)因PM信号质量差被排除。T3自动评分算法得出的平均AHI与人工评分得出的平均AHI相似(分别为19.6±18.9和18.6±19.1)。自动评分得出的T3 AHI与PSG得出的AHI密切相关(r = 0.93)。T3(自动评分AHI)对阻塞性睡眠呼吸暂停综合征(OSA)的存在表现出高度敏感性(100%),使用AHI截断值≥5次/小时排除OSA时具有可接受的特异性(70%)。当更保守地定义OSA的存在(AHI>15次/小时)时,该设备(自动评分)具有高度的敏感性(92%)和特异性(85%)。对于定义为AHI≥5的OSA,T3(自动评分)正确识别了88%的阳性病例和100%的阴性病例。
结论
在这个基于诊所的小样本中,与PSG相比,T3显示出非常好的测量一致性,并且对检测即使是轻度OSA也具有高度敏感性。假阳性似乎是由于与呼吸努力相关的觉醒(RERAs)被自动评分为阻塞性呼吸暂停,可能是由于PSG和便携式监测仪之间流量测量灵敏度的固有差异。