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Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea
Journal article   Open access   Peer reviewed

Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea

Peter R. Eastwood, Maree Barnes, Stuart G. MacKay, John R. Wheatley, David R. Hillman, Xuân-Lan Nguyên, Richard Lewis, Matthew C. Campbell, Boris Pételle, Jennifer H. Walsh, …
The European respiratory journal, Vol.55(1), p.1901320
2020
DOI: https://doi.org/10.1183/13993003.01320-2019
PMCID: PMC6949509
PMID: 31601716
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Published (Version of Record)CC BY V4.0,  Open Access

Abstract

Background and aim: 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. Methods: This 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. Results: 22 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. Conclusions: Bilateral 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.

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Collaboration types
Domestic collaboration
International collaboration
Citation topics
1 Clinical & Life Sciences
1.137 Sleep Science & Circadian Systems
1.137.382 Obstructive Sleep Apnea
Web Of Science research areas
Respiratory System
ESI research areas
Clinical Medicine
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