Combination therapy with mandibular advancement and expiratory positive airway pressure valves reduces obstructive sleep apnea severity.

STUDY OBJECTIVES: Mandibular 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. METHODS: Twenty-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). RESULTS: Compared 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 (DeltaAHI = 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). CONCLUSIONS: Combination 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 TRIALS: Name: 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).