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Published in: Trials 1/2019

Open Access 01-12-2019 | Sleep Apnea | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2019

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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.
Literature
1.
Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013;177(9):1006–14.CrossRefPubMedPubMedCentral
2.
3.
Jennum P, Kjellberg J. Health, social and economical consequences of sleep-disordered breathing: a controlled national study. Thorax. 2011;66(7):560–6.CrossRefPubMed
4.
McNicholas WT, Bassetti CL, Ferini-Strambi L, Pepin JL, Pevernagie D, Verbraecken J, et al. Challenges in obstructive sleep apnoea. Lancet Respir Med. 2018;6(3):170–2.CrossRefPubMed
5.
Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000;342(19):1378–84.CrossRefPubMed
6.
Bradley TD, Floras JS. Obstructive sleep apnoea and its cardiovascular consequences. Lancet. 2009;373(9657):82–93.CrossRefPubMed
7.
Epstein LJ, Kristo D, Strollo PJ Jr, Friedman N, Malhotra A, Patil SP, et al. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009;5(3):263–76.PubMed
8.
Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, et al. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012;8(5):597–619.PubMedPubMedCentral
9.
Peppard PE, Young T, Palta M, Dempsey J, Skatrud J. Longitudinal study of moderate weight change and sleep-disordered breathing. JAMA. 2000;284(23):3015–21.CrossRefPubMed
10.
Kushida CA, Littner MR, Hirshkowitz M, Morgenthaler TI, Alessi CA, Bailey D, et al. Practice parameters for the use of continuous and bilevel positive airway pressure devices to treat adult patients with sleep-related breathing disorders. Sleep. 2006;29(3):375–80.CrossRefPubMed
11.
Sullivan CE, Issa FG, Berthon-Jones M, Eves L. Reversal of obstructive sleep apnoea by continuous positive airway pressure applied through the nares. Lancet. 1981;1(8225):862–5.CrossRefPubMed
12.
Civelek S, Emre IE, Dizdar D, Cuhadaroglu C, Eksioglu BK, Eraslan AK, et al. Comparison of conventional continuous positive airway pressure to continuous positive airway pressure titration performed with sleep endoscopy. Laryngoscope. 2012;122(3):691–5.CrossRefPubMed
13.
Morgenthaler TI, Aurora RN, Brown T, Zak R, Alessi C, Boehlecke B, Chesson AL, Jr., et al. Practice parameters for the use of autotitrating continuous positive airway pressure devices for titrating pressures and treating adult patients with obstructive sleep apnea syndrome: an update for 2007. An American Academy of Sleep Medicine report. Sleep. 2008;31(1):141–7.
14.
Lopez-Campos JL, Garcia Polo C, Leon Jimenez A, Gonzalez-Moya E, Arnedillo A, Fernandez Berni JJ. CPAP titration: different methods for similar clinical results. Eur J Intern Med. 2007;18(3):230–4.
15.
Rabelo FA, Kupper DS, Sander HH, Fernandes RM, Valera FC. Polysomnographic evaluation of propofol-induced sleep in patients with respiratory sleep disorders and controls. Laryngoscope. 2013;123(9):2300–5.CrossRefPubMed
16.
Rotenberg BW, Murariu D, Pang KP. Trends in CPAP adherence over twenty years of data collection: a flattened curve. J Otolaryngol Head Neck Surg. 2016;45(1):43.CrossRefPubMedPubMedCentral
17.
Phillips CL, Grunstein RR, Darendeliler MA, Mihailidou AS, Srinivasan VK, Yee BJ, et al. Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial. Am J Respir Crit Care Med. 2013;187(8):879–87.CrossRefPubMed
18.
Vanderveken OM, Devolder A, Marklund M, Boudewyns AN, Braem MJ, Okkerse W, et al. Comparison of a custom-made and a thermoplastic oral appliance for the treatment of mild sleep apnea. Am J Respir Crit Care Med. 2008;178(2):197–202.CrossRefPubMed
19.
Lettieri CJ, Paolino N, Eliasson AH, Shah AA, Holley AB. Comparison of adjustable and fixed oral appliances for the treatment of obstructive sleep apnea. J Clin Sleep Med. 2011;7(5):439–45.PubMedPubMedCentral
20.
Kato J, Isono S, Tanaka A, Watanabe T, Araki D, Tanzawa H, et al. Dose-dependent effects of mandibular advancement on pharyngeal mechanics and nocturnal oxygenation in patients with sleep-disordered breathing. Chest. 2000;117(4):1065–72.CrossRefPubMed
21.
Remmers J, Charkhandeh S, Grosse J, Topor Z, Brant R, Santosham P, et al. Remotely controlled mandibular protrusion during sleep predicts therapeutic success with oral appliances in patients with obstructive sleep apnea. Sleep. 2013;36(10):1517–25 25A.CrossRefPubMedPubMedCentral
22.
Demko BG. Ten misconceptions that dentists have about treating obstructive sleep apnea. J Dent Sleep Med. 2018;5(3):90–103.
23.
Dieltjens M, Vanderveken OM, Heyning PH, Braem MJ. Current opinions and clinical practice in the titration of oral appliances in the treatment of sleep-disordered breathing. Sleep Med Rev. 2012;16(2):177–85.CrossRefPubMed
24.
Ferguson KA, Ono T, Lowe AA, Al-Majed S, Love LL, Fleetham JA. A short-term controlled trial of an adjustable oral appliance for the treatment of mild to moderate obstructive sleep apnoea. Thorax. 1997;52(4):362–8.CrossRefPubMedPubMedCentral
25.
Mehta A, Qian J, Petocz P, Darendeliler MA, Cistulli PA. A randomized, controlled study of a mandibular advancement splint for obstructive sleep apnea. Am J Respir Crit Care Med. 2001;163(6):1457–61.CrossRefPubMed
26.
Johal A, Gill G, Ferman A, McLaughlin K. The effect of mandibular advancement appliances on awake upper airway and masticatory muscle activity in patients with obstructive sleep apnoea. Clin Physiol Funct Imaging. 2007;27(1):47–53.CrossRefPubMed
27.
Pancer J, Al-Faifi S, Al-Faifi M, Hoffstein V. Evaluation of variable mandibular advancement appliance for treatment of snoring and sleep apnea. Chest. 1999;116(6):1511–8.CrossRefPubMed
28.
Almeida FR, Parker JA, Hodges JS, Lowe AA, Ferguson KA. Effect of a titration polysomnogram on treatment success with a mandibular repositioning appliance. J Clin Sleep Med. 2009;5(3):198–204.PubMedPubMedCentral
29.
Fleury B, Rakotonanahary D, Petelle B, Vincent G, Pelletier Fleury N, Meyer B, et al. Mandibular advancement titration for obstructive sleep apnea: optimization of the procedure by combining clinical and oximetric parameters. Chest. 2004;125(5):1761–7.CrossRefPubMed
30.
Kastoer C, Dieltjens M, Oorts E, Hamans E, Braem MJ, Van de Heyning PH, et al. The use of remotely controlled mandibular positioner as a predictive screening tool for mandibular advancement device therapy in patients with obstructive sleep apnea through single-night progressive titration of the mandible: a systematic review. J Clin Sleep Med. 2016;12(10):1411–21.CrossRefPubMedPubMedCentral
31.
Dort LC, Hadjuk E, Remmers JE. Mandibular advancement and obstructive sleep apnoea: a method for determining effective mandibular protrusion. Eur Respir J. 2006;27(5):1003–9.CrossRefPubMed
32.
Tsai WH, Vazquez JC, Oshima T, Dort L, Roycroft B, Lowe AA, et al. Remotely controlled mandibular positioner predicts efficacy of oral appliances in sleep apnea. Am J Respir Crit Care Med. 2004;170(4):366–70.CrossRefPubMed
33.
Croft CB, Pringle M. Sleep nasendoscopy: a technique of assessment in snoring and obstructive sleep apnoea. Clin Otolaryngol Allied Sci. 1991;16(5):504–9.CrossRefPubMed
34.
Kastoer C, Dieltjens M, Op de Beeck S, Braem MJ, Van de Heyning PH, Vanderveken OM. Remotely controlled mandibular positioning during drug-induced sleep endoscopy toward mandibular advancement device therapy: feasibility and protocol. J Clin Sleep Med. 2018;14(8):1409–13.CrossRefPubMedPubMedCentral
35.
Vroegop AV, Vanderveken OM, Boudewyns AN, Scholman J, Saldien V, Wouters K, et al. Drug-induced sleep endoscopy in sleep-disordered breathing: report on 1,249 cases. Laryngoscope. 2014;124(3):797–802.
36.
Worm-Smeitink M, Gielissen M, Bloot L, et al. The assessment of fatigue: Psychometric qualities and norms for the Checklist individual strength. J Psychom Res. 2017;98:40–46
37.
Johns MW. A new method for measuring daytime sleepiness: the Epworth Sleepiness Scale. Sleep. 1991;14(6):540–5.CrossRefPubMed
38.
Vanderveken OM, Boudewyns AN, Braem MJ, Okkerse W, Verbraecken JA, Willemen M, et al. Pilot study of a novel mandibular advancement device for the control of snoring. Acta Otolaryngol. 2004;124(5):628–33.CrossRefPubMed
39.
Barnes M, McEvoy RD, Banks S, Tarquinio N, Murray CG, Vowles N, et al. Efficacy of positive airway pressure and oral appliance in mild to moderate obstructive sleep apnea. Am J Respir Crit Care Med. 2004;170(6):656–64.CrossRefPubMed
40.
Rabelo FAW, Küper DS, Sander, HH, Fernandes RMF, Valera FCP. Polysomnographic Evaluation of Propofol-Induced Sleep in Patients with Respiratory Sleep Disorders and Controls. Laryngoscope. 2013;123:2300–305.
Metadata
Title
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
Authors
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
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3698-4

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