Kalinix®, an innovative, intelligent, non-invasive, and self-adaptive medical device for effective OSA management.

PURPOSE: Obstructive sleep apnea (OSA) is a rising prevalent disease mediated, in part, by the excessive relaxation of pharyngeal muscles that increases the vulnerability for pharyngeal collapse. At the therapeutic level, the reduced patient’s compliance of continuous positive airway pressure (CPAP) linked with the limitations of alternative OSA treatments, emphasizes the need for novel non-invasive and effective treatment options.

METHODS

This real-world interventional clinical evaluation aims to explore the viability and short-term performance of Kalinix® in a clinically relevant OSA population representative of the routine clinical practice. Kalinix® urge as an innovative, intelligent, non-invasive, multi-sensor and self-adaptive medical device developed to overcome the limitations of the current OSA treatments. Their clinical efficacy, under real-world conditions, was explored in this unicentric and interventional study that included 20 patients with moderate to severe OSA.

RESULTS

The clinical efficacy of Kalinix® was demonstrated by the statistically significant improvements in key OSA clinical parameters, with 55% of patients experiencing improvements > 50% in apnea-hypopnea index (AHI). Additionally, 100% and 42.9% of patients with moderate OSA (baseline AHI ≤ 29) or severe OSA (baseline AHI 30–49) were classified as Kalinix® responders (residual AHI < 15). Moreover, based on investigator-defined clinical criteria (AHI+ oxygen desaturation index [ODI], AHI+ percentage of time with an oxygen saturation < 90% [CT90], and AHI + ODI+CT90), nearly 40% of patients were categorized as good treatment responders. In addition to the clinical benefits observed with Kalinix®, 100% of patients reported satisfaction with the device ergonomics, portability, and performance.

CONCLUSION

Kalinix® showed promising results in the treatment OSA and offers a non-invasive, comfortable, portable, effective, and safe therapeutic option that may contribute to achieving good long-term compliance and clinical outcomes.