Abstract

Abstract Introduction The intra-oral negative air pressure device (iNAP) is designed to develop a negative pressure gradient in the oral cavity of the user. The pressure gradient provides a force to move the tongue and soft palate forward. Previous works show the treatment response rate of intra-oral pressure therapy varying between 25–79%. However, for those OSA patients with very high BMI or AHI, they may need higher pressure to achieve optimizing treatment outcome. Methods To provide an optimizing treatment of intra-oral pressure, 30 patients treated with iNAP successfully completed one baseline PSG and one treatment PSG with in-laboratory pressure adjustment. When conducting the iNAP titration PSG, the initial treatment pressure is 40mmHg. iNAP pressure should be increased by at least 10mmHg an interval no shorter than 15 min. In order to eliminate obstructive respiratory events, iNAP pressure should be increased when observe obstructive apnea or hypopnea or unambiguous snoring. Results A total of 30 patients presented their consent to participate in this study. The mean age of the patients was 51.2 ± 13.97 years, and their mean body mass index (BMI) was 25.87 ± 3.41 kg/m2. The mean baseline AHI was 39.59 ± 20.05 events/h, which decreased significantly to 8.17 ± 8.11 events/h. No significant change in sleep efficacy, and percentage of N1 stage was found in the treatment PSG. However, significant improvements in the percentage of N3 stage, Min SpO2, and arousal index were observed in the treatment PSG. Conclusion In this study, the clinical response rate, as defined by the Sher criteria, was 86% (26/30 patients), when the Tx PSG response was compared with the baseline values. Besides, the mean AHI under final titration pressure is 2.58. The results show that increasing intraoral pressure would help to further improve the sleep apnea. Support (if any) This study was sponsored by Somnics, Inc.

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