The efficacy and safety of an intraoral negative air pressure device in patients with obstructive sleep apnea: a systematic review and meta-analysis.

Study objectives: To evaluate the efficacy and safety of intraoral negative air pressure devices (INAP) in patients with obstructive sleep apnea (OSA).

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 OSA patients who reported the apnea-hypopnea index (AHI). The final update was made on 7 December 2024. The risk-of-bias assessment tool for nonrandomized studies (RoBANS) was applied for quality assessment. RevMan 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 AHI with a mean difference (MD) of 12.4 (95%CI, 7.5 to 17.3), minimum oxygen saturation with MD of -3.6 (95%CI, -5.3 to -1.8), Epworth sleepiness scale with MD of 2.64 (95% CI, 0.23 to 5.05) and oxygen desaturation index (ODI) with MD of 10.8 (95%CI, 7.2 to 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 AHI and ODI. INAP may be a suitable treatment option for selected patients with OSA.

Systematic review registration: Registry: PROSPERO; Identifier: CRD42024510535.