便携式睡眠监测仪诊断青少年阻塞性睡眠呼吸暂停的准确性。
The accuracy of a portable sleep monitor to diagnose obstructive sleep apnea in adolescent patients.
机构信息
University of California San Diego, La Jolla, California.
Rady Children's Hospital, San Diego, California.
出版信息
J Clin Sleep Med. 2021 Jul 1;17(7):1379-1387. doi: 10.5664/jcsm.9202.
STUDY OBJECTIVES
The efficacy of portable-monitor (PM) sleep testing in children is not well understood. While most studies have evaluated PM in a lab setting, the utility of PM in the home environment is relatively unknown. We sought to determine whether home PM accurately diagnoses obstructive sleep apnea in adolescents and to assess patient satisfaction with home PM sleep testing.
METHODS
We evaluated adolescents (age 12-18 years) with suspected obstructive sleep apnea using a PM device. In addition to in-laboratory polysomnography (PSG), all participants had PM testing performed twice, once in their home and once concurrent to in-laboratory PSG. PM was compared to PSG using 2 primary outcomes: the apnea-hypopnea index and oxygen desaturation index. All participants were approached for interview to evaluate their experience with PM sleep testing.
RESULTS
Twenty adolescents participated. Bland-Altman analysis comparing the apnea-hypopnea index and oxygen desaturation index determined by home or in-laboratory PM to in-laboratory PSG revealed mostly agreement; however, some deviations were observed when either parameter was markedly increased. While PM testing tended to underestimate the apnea-hypopnea index, the diagnostic agreement between home PM and PSG was 80% (by the White-Westbrook method). Most preferred PM to PSG and found PM easy to very easy to set up.
CONCLUSIONS
In a small cohort of adolescents, our study supports the application of home PM in the diagnosis of suspected obstructive sleep apnea. Until studies implementing PM using larger cohorts become readily available, the findings from this preliminary study could contribute to adolescents receiving sleep apnea therapy more promptly.
CLINICAL TRIAL REGISTRATION
Registry: ClinicalTrials.gov; Identifier: NCT03748771. At the time of issue publication, this registration is not publicly available because the trial includes a device that is not approved or cleared for use in pediatric populations. Once the device is FDA cleared, the registration will become public.
研究目的
便携式监测仪（PM）在儿童中的睡眠测试效果尚不清楚。虽然大多数研究都在实验室环境中评估了 PM，但 PM 在家庭环境中的效用相对未知。我们旨在确定家庭 PM 是否能准确诊断青少年阻塞性睡眠呼吸暂停，并评估患者对家庭 PM 睡眠测试的满意度。
方法
我们使用 PM 设备评估了疑似阻塞性睡眠呼吸暂停的青少年患者。除了在实验室进行多导睡眠图（PSG）外，所有参与者都进行了两次 PM 测试，一次在家庭中，一次与实验室 PSG 同时进行。PM 与 PSG 比较使用了 2 个主要结果：呼吸暂停低通气指数和氧减饱和度指数。所有参与者都接受了采访，以评估他们对 PM 睡眠测试的体验。
结果
20 名青少年参与了研究。通过 Bland-Altman 分析比较家庭或实验室 PM 确定的呼吸暂停低通气指数和氧减饱和度指数与实验室 PSG 之间的差异，发现大多数情况下存在一致性；然而，当任何一个参数明显增加时，都会观察到一些偏差。虽然 PM 测试往往会低估呼吸暂停低通气指数，但家庭 PM 与 PSG 的诊断一致性为 80%（根据 White-Westbrook 方法）。大多数人更喜欢 PM 而不是 PSG，并且发现 PM 很容易设置。
结论
在一小部分青少年中，我们的研究支持在家中使用 PM 进行疑似阻塞性睡眠呼吸暂停的诊断。在使用更大队列的 PM 进行研究变得更加容易之前，这项初步研究的结果可以帮助青少年更快地接受睡眠呼吸暂停治疗。
临床试验注册
注册机构：ClinicalTrials.gov；标识符：NCT03748771。在发布时，该注册信息尚未公开，因为该试验包含一种尚未获得批准或获准用于儿科人群的设备。一旦该设备获得 FDA 批准，注册信息将公开。
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