Van den Bossche Karlien, Van de Perck Eli, Wellman Andrew, Kazemeini Elahe, Willemen Marc, Verbraecken Johan, Vanderveken Olivier M, Vena Daniel, Op de Beeck Sara
Department of ENT and Head and Neck Surgery, Antwerp University Hospital, Edegem, Belgium.
Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk, Belgium.
Front Neurol. 2021 Dec 7;12:768973. doi: 10.3389/fneur.2021.768973. eCollection 2021.
Obstructive sleep apnea (OSA) is increasingly recognized as a complex and heterogenous disorder. As a result, a "one-size-fits-all" management approach should be avoided. Therefore, evaluation of pathophysiological endotyping in OSA patients is emphasized, with upper airway collapse during sleep as one of the main features. To assess the site(s) and pattern(s) of upper airway collapse, natural sleep endoscopy (NSE) is defined as the gold standard. As NSE is labor-intensive and time-consuming, it is not feasible in routine practice. Instead, drug-induced sleep endoscopy (DISE) is the most frequently used technique and can be considered as the clinical standard. Flow shape and snoring analysis are non-invasive measurement techniques, yet are still evolving. Although DISE is used as the clinical alternative to assess upper airway collapse, associations between DISE and NSE observations, and associated flow and snoring signals, have not been quantified satisfactorily. In the current project we aim to compare upper airway collapse identified in patients with OSA using endoscopic techniques as well as flow shape analysis and analysis of tracheal snoring sounds between natural and drug-induced sleep. This study is a blinded prospective comparative multicenter cohort study. The study population will consist of adult patients with a recent diagnosis of OSA. Eligible patients will undergo a polysomnography (PSG) with NSE overnight and a DISE within 3 months. During DISE the upper airway is assessed under sedation by an experienced ear, nose, throat (ENT) surgeon using a flexible fiberoptic endoscope in the operating theater. In contrast to DISE, NSE is performed during natural sleep using a pediatric bronchoscope. During research DISE and NSE, the standard set-up is expanded with additional PSG measurements, including gold standard flow and analysis of tracheal snoring sounds. This project will be one of the first studies to formally compare collapse patterns during natural and drug-induced sleep. Moreover, this will be, to the authors' best knowledge, the first comparative research in airflow shape and tracheal snoring sounds analysis between DISE and NSE. These novel and non-invasive diagnostic methods studying upper airway mechanics during sleep will be simultaneously validated against DISE and NSE. www.ClinicalTrials.gov, identifier: NCT04729478.
阻塞性睡眠呼吸暂停（OSA）越来越被认为是一种复杂的异质性疾病。因此，应避免采用“一刀切”的管理方法。所以，强调对OSA患者进行病理生理亚型评估，睡眠期间上气道塌陷是主要特征之一。为了评估上气道塌陷的部位和模式，自然睡眠内镜检查（NSE）被定义为金标准。由于NSE劳动强度大且耗时，在常规实践中不可行。相反，药物诱导睡眠内镜检查（DISE）是最常用的技术，可被视为临床标准。气流形态和打鼾分析是无创测量技术，但仍在不断发展。尽管DISE被用作评估上气道塌陷的临床替代方法，但DISE与NSE观察结果以及相关气流和打鼾信号之间的关联尚未得到令人满意的量化。在当前项目中，我们旨在比较使用内镜技术以及气流形态分析和气管打鼾声音分析在自然睡眠和药物诱导睡眠中OSA患者所识别出的上气道塌陷情况。 本研究是一项双盲前瞻性比较多中心队列研究。研究人群将包括近期诊断为OSA的成年患者。符合条件的患者将在夜间进行一次伴有NSE的多导睡眠图（PSG）检查，并在3个月内进行一次DISE检查。在DISE期间，由经验丰富的耳鼻喉（ENT）外科医生在手术室使用柔性纤维内窥镜在镇静状态下对上气道进行评估。与DISE不同，NSE是在自然睡眠期间使用小儿支气管镜进行的。在研究DISE和NSE期间，标准设置通过额外的PSG测量进行扩展，包括金标准气流和气管打鼾声音分析。 该项目将是首批正式比较自然睡眠和药物诱导睡眠期间塌陷模式的研究之一。此外，据作者所知，这将是第一项在DISE和NSE之间进行气流形态和气管打鼾声音分析比较的研究。这些研究睡眠期间上气道力学的新型无创诊断方法将同时针对DISE和NSE进行验证。 临床试验.gov网站，标识符：NCT04729478。
