Comparison of Drug-Induced Sleep Endoscopy and Natural Sleep Endoscopy in the Assessment of Upper Airway Pathophysiology During Sleep: Protocol and Study Design

Karlien Van den Bossche, Eli Van de Perck, Andrew Wellman, Elahe Kazemeini, Marc Willemen, Johan Verbraecken, Olivier M Vanderveken, Daniel Vena, Sara Op de Beeck, Karlien Van den Bossche, Eli Van de Perck, Andrew Wellman, Elahe Kazemeini, Marc Willemen, Johan Verbraecken, Olivier M Vanderveken, Daniel Vena, Sara Op de Beeck

Abstract

Study Objectives: 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. Methods: 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. Conclusions: 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. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04729478.

Keywords: OSA (obstructive sleep apnea); diagnosis; endotyping; personalized medicine; upper airway obstruction.

Conflict of interest statement

AW reports grants and personal fees from SomniFix; grants from Sanofi and fees from Nox, Apnimed, Bayer, and Inspire Medical Systems outside the submitted work. JV reports grants and fees from SomnoMed, AirLiquide, Vivisol, Mediq Tefa, Medidis, OSG, Agfa-Gevaert, Accuramed, Bioprojet, Jazz Pharmaceutics, Desitin, Idorsia, Nightbalance, Inspire Medical Systems, Heinen and Löwenstein, Ectosense, Philips, and ResMed outside the submitted work. OV reports grants from Inspire Medical Systems, Nightbalance, GlaxoSmithKline, and LivaNova at the Antwerp University Hospital outside the submitted work. The funders were not involved in the study design, collection, the writing of this article or the decision to submit it for publication. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Van den Bossche, Van de Perck, Wellman, Kazemeini, Willemen, Verbraecken, Vanderveken, Vena and Op de Beeck.

Figures

Figure 1
Figure 1
Generic study protocol. AHI, apnea-hypopnea index; BMI, body mass index; CPAP, continuous positive airway pressure; DISE, drug-induced sleep endoscopy; EEG, electroencephalography; EMG, electromyography; NSE, natural sleep endoscopy; OSA, obstructive sleep apnea; PSG, polysomnography.
Figure 2
Figure 2
Endoscopic classification systems. HMS, Harvard Medical School. VOTE classification system (26, 46). HMS classification system (22, 27, 29).
Figure 3
Figure 3
Overview of the set-up to simultaneously measure airflow and capture endoscopy footage. ECG, electrocardiography; EEG, electroencephalography; EMG, electromyography; EOG, electrooculography.

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