Abstract
STUDY OBJECTIVES: To evaluate the efficacy and safety of intraoral negative air pressure (iNAP) devices in patients with obstructive sleep apnea. METHODS: A systematic search without language restrictions was conducted in the Ovid Medline, Embase, and Scopus databases to identify all original studies on the effects of iNAP devices in adult patients with obstructive sleep apnea who reported the apnea-hypopnea index. The final update was made on December 7, 2024. The risk of bias assessment tool for nonrandomized studies was applied for quality assessment. Review Manager was used to conduct statistical analysis. RESULTS: Of the 72 originally retrieved articles, 9 studies were included that involved a total of 445 individuals. Meta-analysis of the pooled data showed that, following iNAP treatment, the participants had a significant improvement in mean apnea-hypopnea index with a mean difference of 12.4 (95% confidence interval, 7.5-17.3), minimum oxygen saturation with mean difference of -3.6 (95% confidence interval, -5.3 to -1.8), Epworth sleepiness scale with mean difference of 2.64 (95% confidence interval, 0.23-5.05) and oxygen desaturation index with mean difference of 10.8 (95% confidence interval, 7.2-14.3). Participants also had a trend of improvement in the percentages of time spent with oxygen saturation ≥ 90% after treatment but did not reach statistical significance. The most common adverse events related to the device were oral tissue discomfort and irritation. No serious adverse events were reported. CONCLUSIONS: Treatment with iNAP devices significantly improved apnea-hypopnea index and oxygen desaturation index. iNAP may be a suitable treatment option for selected patients with obstructive sleep apnea. CITATION: Puvatanond C, Kasemsuk N, Banhiran W. The efficacy and safety of an intraoral negative air pressure device in patients with obstructive sleep apnea: a systematic review and meta-analysis. J Clin Sleep Med. 2025;21(11):1969-1977.