• Victor Lai, Benjamin K Tong, Carolin Tran, Andrea Ricciardiello, Michelle Donegan, Nicholas P Murray, Jayne C Carberry, and Danny J Eckert.
• Neuroscience Research Australia (NeuRA), Sydney, NSW, Australia.
• Sleep. 2019 Aug 1; 42 (8).

Study ObjectivesMandibular advancement splint (MAS) therapy is a well-tolerated alternative to continuous positive airway pressure for obstructive sleep apnea (OSA). Other therapies, including nasal expiratory positive airway pressure (EPAP) valves, can also reduce OSA severity. However, >50% of patients have an incomplete or no therapeutic response with either therapy alone and thus remain at risk of adverse health outcomes. Combining these therapies may yield greater efficacy to provide a therapeutic solution for many incomplete/nonresponders to MAS therapy. Thus, this study evaluated the efficacy of combination therapy with MAS plus EPAP in incomplete/nonresponders to MAS alone.MethodsTwenty-two people with OSA (apnea-hypopnea index [AHI] = 22 [13, 42] events/hr), who were incomplete/nonresponders (residual AHI > 5 events/hr) on an initial split-night polysomnography with a novel MAS device containing an oral airway, completed an additional split-night polysomnography with MAS + oral EPAP valve and MAS + oral and nasal EPAP valves (order randomized).ResultsCompared with MAS alone, MAS + oral EPAP significantly reduced the median total AHI, with further reductions with the MAS + oral/nasal EPAP combination (15 [10, 34] vs. 10 [7, 21] vs. 7 [3, 13] events/hr, p < 0.01). Larger reductions occurred in supine nonrapid eye movement AHI with MAS + oral/nasal EPAP combination therapy (ΔAHI = 23 events/hr, p < 0.01). OSA resolved (AHI < 5 events/hr) with MAS + oral/nasal EPAP in nine individuals and 13 had ≥50% reduction in AHI from no MAS. However, sleep efficiency was lower with MAS + oral/nasal EPAP versus MAS alone or MAS + oral EPAP (78 ± 19 vs. 87 ± 10 and 88 ± 10% respectively, p < 0.05).ConclusionsCombination therapy with a novel MAS device and simple oral or oro-nasal EPAP valves reduces OSA severity to therapeutic levels for a substantial proportion of incomplete/nonresponders to MAS therapy alone.Clinical TrialsName: Targeted combination therapy: Physiological mechanistic studies to inform treatment for obstructive sleep apnea (OSA)URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372279 Registration: ACTRN12617000492358 (Part C).© Sleep Research Society 2019. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

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