Prevention of leakage due to mouth opening through applying an oral shield device (Sominpax™) during nasal CPAP therapy of patients with obstructive sleep apnea.

Abstract

BACKGROUND/OBJECTIVE\nThe first line treatment for obstructive sleep apnea (OSA) is nasal continuous positive airway pressure (nCPAP), for which a variety of masks are available. While nasal masks (NM) are the first choice; oronasal masks (ONM) are also frequently used to prevent mouth dryness resulting from mouth opening. Our cross-sectional, prospective, randomized, un-blinded study addressed the efficacy of wearing an oral shield in addition to NM in preventing mouth leakage METHODS: Patients with OSA and established therapy using NM and complaining about mouth dryness (n\xa0=\xa029) underwent three polysomnographies (PSGs) using NM, ONM or a nose mask in combination with an oral shield (NMS). Mask leakage was continuously documented and objective sleep quality was assessed.\n\n\nRESULTS\nThere were significant differences in the apnea-hypopnea-index (AHI) between ONM (8.5/h; SD 6,7) and NM/nasal mask combined with oral shield device (NMS) (2.6/h; SD 2,3; 2.7/h; SD 2,6) (p\xa0<\xa00,05) as well as in leakage [ONM (39.7\xa0l/min SD 12,4); NM (34.6\xa0l/min SD 9,4); NMS (33.1\xa0l/min SD 9,6)] (p\xa0=\xa00.011). Furthermore, analysis of sleep quality (NREM3) favored NM and NMS over ONM (p\xa0=\xa00.02). There were no significant differences between NM and NMS in any objective outcome.\n\n\nCONCLUSIONS\nOur data consistently confirmed the NM as the first choice for continuous positive airway pressure (CPAP) therapy of OSA. Notably, we demonstrated a high potential of the oral shield for patients with mouth opening to achieve additional comfort and thereby possibly compliance, without affecting nCPAP therapy effectiveness.