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

BACKGROUND AND AIM: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSIONS: 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.