Bilateral Hypoglossal Nerve Stimulation for Treatment of Adult Obstructive Sleep Apnea.

Abstract

Hypoglossal Nerve Stimulation (HNS) decreases Obstructive Sleep Apnea (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. This prospective, open-label, non-randomised, single arm treatment study was conducted at eight centres in three countries (Australia, France, UK). Primary outcomes were incidence of device-related Serious Adverse Events (SAEs) and change in the Apnea-Hypopnea Index (AHI). The secondary outcome was the change in the 4% Oxygen Desaturation Index (ODI). Additional outcomes included measures of sleepiness, quality of life, snoring, and device use. This trial was registered with ClinicalTrials.gov, number NCT03048604. From 27 implanted participants (63% male, aged 55.9±12.0 years, BMI 27.4±3.0 kg·m-2), 22 completed the protocol. At 6 months BMI was unchanged (p=0.85), AHI decreased from 23.7±12.2 to 12.9±10.1 events·hr-1, a mean change of 10.8 events·hr-1 (p<0.001); ODI decreased from 19.1±11.2 to 9.8±6.9 events·hr-1, a mean change of 9.3 events·hr-1 (p<0.001). Daytime sleepiness (ESS, p=0.01) and sleep-related quality of life (FOSQ-10, p=0.02) both significantly improved. The number of bed partners reporting loud, very intense snoring, or leaving the bedroom due to participant snoring decreased from 96% to 35%. Ninety-one percent of participants reported device use >5 days per week, and 77% reported use for >5 hrs per night. No device-related SAE occurred during the 6-months post-implantation period. Bilateral HNS using the Genio™ system reduces OSA severity and improve quality of life without device related complication. The results are comparable with previously published HNS systems despite minimal implanted components and a simple stimulation algorithm.