Remotely controlled mandibular positioning of oral appliance therapy during polysomnography and drug-induced sleep endoscopy compared with conventional subjective titration in patients with obstructive sleep apnea: protocol for a randomized crossover trial

Marijke Dieltjens, Marc J Braem, Sara Op de Beeck, Anneclaire V M T Vroegop, Elahe Kazemeini, Eli Van de Perck, Jolien Beyers, Chloé Kastoer, Kristien Wouters, Marc Willemen, Johan A Verbraecken, Olivier M Vanderveken, Marijke Dieltjens, Marc J Braem, Sara Op de Beeck, Anneclaire V M T Vroegop, Elahe Kazemeini, Eli Van de Perck, Jolien Beyers, Chloé Kastoer, Kristien Wouters, Marc Willemen, Johan A Verbraecken, Olivier M Vanderveken

Abstract

Background: The amount of mandibular protrusion is a key factor in optimizing the efficacy of mandibular advancement device (MAD) therapy in an individual patient diagnosed with obstructive sleep apnea. This process is called titration and is generally based on resolution of subjective symptoms like snoring and/or daytime sleepiness as a function of protrusion. An objective approach uses a remotely controlled mandibular positioner (RCMP) during a full-night polysomnography (PSG), in analogy with continuous positive airway pressure (CPAP) titration. More recently, the feasibility of RCMP use during drug-induced sleep endoscopy (DISE) titration was reported.

Methods: This randomized crossover trial will compare DISE-assisted titration to PSG-guided titration, as well as with the conventional subjective titration method. The primary outcome is the actual mandibular protrusive position found to be the most optimal for each tested titration procedure. Furthermore, the therapeutic efficacy will be compared among the different titration modalities using level 1 sleep studies.

Discussion: Currently, the optimal titration of MAD therapy is most often based on 'trial and error'. The conventional method relies on subjective improvement in symptoms, although this may not provide the most accurate indicator for efficient titration. Therefore, relying on objective criteria in the titration process should be advantageous. In analogy with CPAP, titration of the most optimal mandibular protrusion could be performed using RCMP during an overnight titration PSG. Recently, it was shown that titration under direct visualization of upper airway patency and collapsibility is feasible using the RCMP during DISE. However, no clinical results for such a procedure are as yet available. This study is the first to compare the most optimal mandibular protrusive position according to three titration procedures, as well as to compare the therapeutic efficacy of these titration methods.

Trial registration: ClinicalTrials.gov, NCT03716648 . Registered on 23 October 2018.

Keywords: Apnea–hypopnea index; Mandibular advancement device; Sleep-disordered breathing.

Conflict of interest statement

MJB and OMV hold a research grant from SomnoMed. OMV has the following potential conflicts of interests: research support and lecture fees from Inspire Medical Systems, research grant from and consultancy for Philips Respironics, research grant and lecture fees from SomnoMed, consultancy for Nyxoah, consultancy for Galvani, research support from ReVent, research support from Nightbalance and part of the advisory board of Zephyr. The other 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.

Figures

Fig. 1
Fig. 1
Schematic overview of the study design. Patients will undergo three titration procedures —subjective titration (green), titration PSG (orange) and, titration DISE (yellow) — in randomized order. This leads to six different possible sequences. A 1-week washout period is integrated between the different titration procedures. A follow-up sleep study is performed at the end of each titration method. DISE, drug-induced sleep endoscopy; MAD, mandibular advancement device; PSG, polysomnography
Fig. 2
Fig. 2
Schedule of protocol assessments following Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). Interventions and assessments will be administered at different time points (indicated by X). See text for more details. CIS20R, Checklist Individual Strength; DISE, drug-induced sleep endoscopy; PSG, polysomnography; RCT, randomized crossover trial; VAS, visual analog scale
Fig. 3
Fig. 3
Schematic overview of the commercially available remotely controlled mandibular positioner (RCMP) device (MATRx™; Zephyr Sleep Technologies Inc., Calgary, Canada). Left: the controller that receives commands from the device software. Right: the motorized RCMP attached to disposable upper and lower dental impression trays. This schematic overview was drawn by our research group

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