Development and the Effectiveness of a Nasal Breathing Stimulator Combined with an Oral Appliance for Treating Obstructive Sleep Apnea

Objective: Many obstructive sleep apnea（OSA）patients have nasal obstruction. Further, most patients discontinue wearing an oral appliance（OA）for improving respiration due to nasal obstruction. We aimed to develop a nasal breathing stimulator（NBS）for use in combination with an OA to promote nasal breathing. Methods: Thirteen OSA patients wore a NBS, Max-Air Nose Corns ® , Mute with hole ® , which expands the nasal cavity from the inside, and Breathe Right ® , which expands the nasal cavity from the outside, and compared the resultant changes in respiratory measures with those when a device was not used. The inspiratory flow rate（peak nasal inspiratory flow: PNIF）and visual analogue scale（VAS）scores were measured under five conditions. Furthermore, PNIF was measured under four conditions: OA（-）NBS（-）, OA（+）NBS（-）, OA（-）NBS（+）, and OA（+）NBS（+）, and a sleep test was performed. Results: PNIF was significantly higher when wearing an NBS compared with the other four devices（p < 0.001）. In addition, PNIF was significantly higher in OA（+）NBS（+） than that in the other three conditions（p < 0.001）, and OA（+）NBS（+）improved the respiratory disturbance index（p < 0.001）, lowest SpO 2（ p < 0.001）, and Epworth sleepiness scale（ESS）score（p < 0.001）on the sleep test. Discussion: Wearing the NBS improved breathing in patients who did not benefit from OA treatment alone and in those who discontinued OA use due to nasal obstruction.