P. Eastwood, M. Barnes, S. MacKay et al
European Respiratory Journal 2020 55: 1901320; DOI: 10.1183/13993003.01320-2019
Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity via genioglossus muscle activation and decreased upper airway collapsibility. This study assessed the safety and effectiveness at 6 months post-implantation of a novel device delivering bilateral HNS via a small implanted electrode activated by a unit worn externally, to treat OSA: the Genio™ system. 22 out of 27 participants (63% male, aged 55.9±12.0 years, body mass index 27.4±3.0 kg·m−2) completed the protocol. AHI decreased from 23.7±12.2 to 12.9±10.1 events·h−1 (p<0.001). Daytime sleepiness (Epworth Sleepiness Scale; p=0.01) and sleep-related quality of life (Functional Outcomes of Sleep Questionnaire-10; p=0.02) both improved significantly. No device-related serious adverse events occurred.The authors conclude that the results are comparable with previously published HNS systems despite minimal implanted components and a simple stimulation algorithm.