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; Andrew C Jones; Carsten E Palme; Alain Bizon; Nicole Meslier; Chloé Bertolus; Kathleen J Maddison; Laurent Laccourreye; Guillaume Raux; Katleen Denoncin; Valérie Attali; Frédéric Gagnadoux; Sandrine H Launois

doi:10.1183/13993003.01320-2019

Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea

Eur Respir J. 2020 Jan 9;55(1):1901320. doi: 10.1183/13993003.01320-2019. Print 2020 Jan.

Authors

Peter R Eastwood^{1

2}, Maree Barnes^{3

4}, Stuart G MacKay^{5

6

7

8}, John R Wheatley^{9

10

11}, David R Hillman^{12

2}, Xuân-Lan Nguyên^{13

14}, Richard Lewis^{15

16}, Matthew C Campbell^{3

4}, Boris Pételle¹⁷, Jennifer H Walsh^{12

2}, Andrew C Jones^{5

6

7}, Carsten E Palme^{10

18}, Alain Bizon¹⁹, Nicole Meslier^{20

21}, Chloé Bertolus^{22

23}, Kathleen J Maddison^{12

2}, Laurent Laccourreye¹⁹, Guillaume Raux²⁴, Katleen Denoncin²⁴, Valérie Attali^{14

22}, Frédéric Gagnadoux^{20

21}, Sandrine H Launois^{13

14}

Affiliations

¹ Centre for Sleep Science, School of Human Sciences, University of Western Australia, Perth, Australia peter.eastwood@health.wa.gov.au.
² West Australian Sleep Disorders Research Institute, Sir Charles Gairdner Hospital, Perth, Australia.
³ Institute for Breathing and Sleep, Austin Hospital, Heidelberg, Australia.
⁴ University of Melbourne, Parkville, Australia.
⁵ Illawarra ENT Head and Neck Clinic, Wollongong, Australia.
⁶ Wollongong Hospital, Illawarra Shoalhaven Local Health District (ISLHD), Wollongong, Australia.
⁷ Graduate School of Medicine, University of Wollongong, Wollongong, Australia.
⁸ Woolcock Institute of Medical Research, Glebe, Australia.
⁹ Dept of Respiratory and Sleep Medicine, Westmead Hospital, Westmead, Australia.
¹⁰ University of Sydney at Westmead Hospital, Westmead, Australia.
¹¹ Ludwig Engel Centre for Respiratory Research, The Westmead Institute for Medical Research, Westmead, Australia.
¹² Centre for Sleep Science, School of Human Sciences, University of Western Australia, Perth, Australia.
¹³ Unité de Somnologie et Fonction Respiratoire, Hopital St Antoine, Paris, France.
¹⁴ Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.
¹⁵ Dept Otolaryngology, Head and Neck Surgery, Royal Perth Hospital, Perth, Australia.
¹⁶ Hollywood Private Hospital, Perth, Australia.
¹⁷ Service ORL Chirurgie de la Face et du Cou, Hôpital Tenon, AP-HP, Paris, Sorbonne Université, Paris, France.
¹⁸ The Dept of Otolaryngology Head Neck Surgery, Westmead Hospital, Westmead, Australia.
¹⁹ Dept Otolaryngology, Head and Neck Surgery, University Hospital of Angers, Angers, France.
²⁰ Dept of Respiratory and Sleep Medicine, University Hospital of Angers, Angers, France.
²¹ INSERM UMR 1063 "SOPAM", University of Angers, Angers, France.
²² AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service des Pathologies du Sommeil (Département "R3S"), Paris, France.
²³ AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Stomatologie et Chirurgie Maxillo-faciale, Paris, France.
²⁴ Nyxoah, S.A., Mont-Saint-Guibert, Belgium.

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.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Adult
Australia
Female
France
Humans
Hypoglossal Nerve*
Male
Prospective Studies
Quality of Life
Sleep Apnea, Obstructive* / therapy
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT03048604
ANZCTR/ACTRN12614000338662