Somnics continuously monitors iNAP patients in the market. For iNAP Lite (predecessor to iNAP One), data was collected from December 15, 2017, to December 15, 2020, involving a total of 374 individuals. No serious adverse events were reported, but there were 12 cases of non-serious adverse reactions, such as excessive salivation, dry mouth, and nasal congestion, which did not require further medical treatment.

Regarding iNAP One, data was collected from October 23, 2019, to October 23, 2022, involving a total of 341 individuals. No serious adverse events were reported, but there were 5 cases of non-serious adverse reactions, such as excessive salivation, dry mouth, and nasal congestion, which did not require further medical treatment.

The clinical research literature (Cheng et al., 2021)* demonstrated significant clinical benefits of the product for 24 out of 32 eligible patients with obstructive sleep apnea (OSA). The two key indicators, "Mean Apnea-Hypopnea Index (AHI)" and "Mean Oxygen Desaturation Index (ODI)," both showed significant improvement: Mean AHI decreased from 32.0±11.3 to 8.7±9.4, and Mean ODI decreased from 24.0±10.9 to 8.0±8.9. During the entire study period, there were only two unrelated events reported by two patients, which included mild chest tightness and mild soreness of the waist. No medical device-related adverse events, abnormal oral or dental conditions, or severe adverse events (SAEs) were reported in the safety analysis cohort.

* Cheng CY, Chen CC, Lo MT, Guilleminault C, Lin CM. "Evaluation of efficacy and safety of intraoral negative air pressure device in adults with obstructive sleep apnea in Taiwan." Sleep Med. 2021 May;81:163-168.