Kalinix® is an innovative, intelligent, safe, noninvasive, multi-sensor, and self-adaptive medical device.A real-world study from Spain demonstrates the efficacy and safety of Kalinix®, a novel device for the management of obstructive sleep apnoea (OSA).
“Kalinix® is an innovative, intelligent, safe, noninvasive, multi-sensor, and self-adaptive medical device … developed to overcome the current limitations of OSA treatments by promoting upper airway opening through targeted electro-therapeutic stimulation of the genioglossus muscle,” the investigators said.
The mean apnoea-hypopnoea index (AHI) significantly decreased from baseline (from 42.9 to 20.7; p<0.001), with all patients exhibiting ≥10 percent improvement (55 percent with >50 percent improvement). [Sleep Breath 2026;30:148]
Other key OSA parameters that improved following device use were the duration of hypopnoea events (from 26.1 to 22.1 s; p<0.001), total events per hour (apnoea: from 25.3 to 10.3; p<0.05; hypopnoea: from 17.7 to 10.4; p<0.01), and oxygen desaturation index (ODI; from 38 to 23.6; p<0.001).
According to the AHI, ODI, and CT90* criteria, approximately 45 percent of the participants were classified as ‘good responders.’ The proportion of responders (residual AHI <15) decreased as disease severity increased (moderate OSA: 100 percent; severe OSA: 42.9 percent; very severe OSA: 16.7 percent).
“Taken together, [these] results highlight the clinical relevance of [the device], supporting its efficacy in the improvement of OSA severity and respiratory parameters,” the researchers said.
Safety, patient satisfaction
The mean stimulation intensity was approximately 42 percent to initiate upper airway opening and 70 percent for maximal airway opening. The mean patient-perception intensity was approximately 70 percent.
The maximum tolerated device intensity was approximately 95 percent. “[M]ost patients’ records clustered above 90 percent, which reflects high device acceptability,” the investigators said.
There were no adverse events or treatment-related side effects during the study.
“Collectively, these findings suggest that the [device’s] physiologic effect threshold … occurs below conscious patient perception and supports a favourable safety profile,” they said.
Sixty percent of participants rated their OSA as ‘bad’ or ‘very bad’ at the beginning of the study. By study end, all participants were highly satisfied with device ergonomics and portability, while 90 percent were highly satisfied with performance (ie, improvement in patient-perceived quality of nocturnal rest). The overall satisfaction rate was 80 percent. The device received a score of 4.8 on a recommendation scale ranging from 0 to 5.
Tx alternatives warranted
The most common treatments for OSA include sleep hygiene, weight loss, positional therapy, and continuous positive airway pressure (CPAP). However, treatment adherence may be impacted by factors including patient-device interface and discomfort. [World J Otorhinolaryngol Head Neck Surg 2015;1:17-27; Expert Rev Respir Med 2021;15:1447-1460]
“[Given] the reduced compliance with CPAP and the limitations of alternative OSA therapies, there is a growing need for novel noninvasive and effective therapeutic devices,” the investigators noted.
The study included 20 patients with moderate-to-severe OSA (mean age 58.4 years, 70 percent men). Of these, 30 percent had moderate OSA (AHI 15–29), 35 percent had severe OSA (AHI 30–49), and 30 percent had very severe OSA (AHI ≥50).
“The device showed promising results in the treatment of OSA, [offering] a noninvasive, comfortable, portable, effective, and safe therapeutic option that may contribute to achieving good long-term compliance and clinical outcomes,” the researchers said.
The findings support the device’s potential clinical relevance and efficacy under real-world conditions, they added, calling for larger and long-term studies to verify its therapeutic benefits.