Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea

Abstract

Background and aimHypoglossal 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.MethodsThis prospective, open-label, non-randomised, single-arm treatment study was conducted at eight centres in three countries (Australia, France and the UK). Primary outcomes were incidence of device-related serious adverse events and change in the apnoea–hypopnoea 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.Results22 out of 27 implanted participants (63% male, aged 55.9±12.0 years, body mass index (BMI) 27.4±3.0 kg·m−2) 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·h−1, a mean change of 10.8 events·h−1 (p<0.001); and ODI decreased from 19.1±11.2 to 9.8±6.9 events·h−1, a mean change of 9.3 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. The number of bed partners reporting loud, very intense snoring, or leaving the bedroom due to participant snoring decreased from 96% to 35%. 91% of participants reported device use >5 days per week, and 77% reported use for >5 h per night. No device-related serious adverse events occurred during the 6-month post-implantation period.ConclusionsBilateral HNS using the Genio™ system reduces OSA severity and improves quality of life without device-related complications. The results are comparable with previously published HNS systems despite minimal implanted components and a simple stimulation algorithm.

Surgical management of obstructive sleep apnoea: A position statement of the Australasian Sleep Association*

“…64 Results from the retrospective and prospective ADHERE Registry of 10 tertiary care hospitals in Germany and the USA (no BMI limit) showed significant improvement in both objective and patient-reported OSA outcomes, demonstrating a decrease from baseline to the post-titration review in mean AHI (±SD) of 35.6 ± 15.3 to 10.2 ± 12.9 (P < 0.0001), and a decrease in ESS score from 11.9 ± 5.5 to 7.5 ± 4.7 (P < 0.0001). 65 In Australia, the Genio-Nyxoah system offering bilateral nerve stimulation with an implantable device, triggered by an external stimulator set off a duty cycle, has recent publications to support a role in OSA therapy, 66 with a further study ('BETTER SLEEP') underway.…”

“…In Australia, the Genio‐Nyxoah system offering bilateral nerve stimulation with an implantable device, triggered by an external stimulator set off a duty cycle, has recent publications to support a role in OSA therapy, 66 with a further study (‘BETTER SLEEP’) underway.…”

<p>Hypoglossal Nerve Stimulation in the Treatment of Obstructive Sleep Apnea: Patient Selection and New Perspectives</p>

“…Recently, the new Genio™ system (Nyxoah SA, Mont-Saint-Guibert, Belgium) has recently obtained CE Mark approval (2019) after finishing successful clinical trials. 17 Its principal difference is that the energy battery is placed outside of the body and the stimulator implant (SI) is designed to be placed in the chin area, like a "saddle on a horse" on the genioglossus muscle, in contact with both branches of the hypoglossal nerve with the advantage of bilateral nerve stimulation.…”

Consistent and Efficient Modeling of the Nonlinear Properties of Ferroelectric Materials in Ceramic Capacitors for Frugal Electronic Implants

“…This will increase the degree of miniaturization in electronic implants because there will be no need to use dedicated sensors or other active electronic components. Electronic implants with inductive power supply, such as retinal implants [ 1 , 6 , 7 , 9 ], cochlear implants [ 29 , 30 ], and the hypoglossal nerve stimulator GenioTM (Nyxoah SA, Mont-Saint-Guibert, Belgium) [ 31 ] would be particularly suitable for this purpose.…”