Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea
Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity 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 a small implanted...
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| Published in | The European respiratory journal Vol. 55; no. 1; p. 1901320 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
European Respiratory Society
01.01.2020
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| Subjects | |
| Online Access | Get full text |
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| Abstract | Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity
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
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 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.
22 out of 27 implanted participants (63% male, aged 55.9±12.0 years, body mass index (BMI) 27.4±3.0 kg·m
) 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
, a mean change of 10.8 events·h
(p<0.001); and ODI decreased from 19.1±11.2 to 9.8±6.9 events·h
, a mean change of 9.3 events·h
(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.
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. |
|---|---|
| AbstractList | Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity
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
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 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.
22 out of 27 implanted participants (63% male, aged 55.9±12.0 years, body mass index (BMI) 27.4±3.0 kg·m
) 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
, a mean change of 10.8 events·h
(p<0.001); and ODI decreased from 19.1±11.2 to 9.8±6.9 events·h
, a mean change of 9.3 events·h
(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.
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. A new method of hypoglossal nerve stimulation to treat sleep apnoea does so bilaterally via an implanted neurostimulator activated externally. Its simplicity and relative non-invasiveness have not compromised its effectiveness relative to older methods. http://bit.ly/2lDCeif 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.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.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.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 NCT03048604.22 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.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.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.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. 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. |
| Author | Wheatley, John R. Meslier, Nicole Maddison, Kathleen J. Denoncin, Katleen Palme, Carsten E. Bertolus, Chloé Jones, Andrew C. Campbell, Matthew C. Nguyên, Xuân-Lan Walsh, Jennifer H. MacKay, Stuart G. Bizon, Alain Hillman, David R. Launois, Sandrine H. Raux, Guillaume Eastwood, Peter R. Attali, Valérie Lewis, Richard Barnes, Maree Pételle, Boris Laccourreye, Laurent Gagnadoux, Frédéric |
| AuthorAffiliation | 2 West Australian Sleep Disorders Research Institute, Sir Charles Gairdner Hospital, Perth, Australia 3 Institute for Breathing and Sleep, Austin Hospital, Heidelberg, Australia 23 Nyxoah, S.A., Mont-Saint-Guibert, Belgium 5 Illawarra ENT Head and Neck Clinic, Wollongong, Australia 6 Wollongong Hospital, Illawarra Shoalhaven Local Health District (ISLHD), Wollongong, Australia 9 Dept of Respiratory and Sleep Medicine, Westmead Hospital, Westmead, Australia 16 Service ORL Chirurgie de la Face et du Cou, Hôpital Tenon, AP-HP, Paris, Sorbonne Université, Paris, France 13 Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France 1 Centre for Sleep Science, School of Human Sciences, University of Western Australia, Perth, 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 7 Graduate School of Medicine, University o |
| AuthorAffiliation_xml | – name: 15 Hollywood Private Hospital, Perth, Australia – name: 8 Woolcock Institute of Medical Research, Glebe, Australia – name: 10 University of Sydney at Westmead Hospital, Westmead, Australia – name: 2 West Australian Sleep Disorders Research Institute, Sir Charles Gairdner Hospital, Perth, Australia – name: 17 The Dept of Otolaryngology Head Neck Surgery, Westmead Hospital, Westmead, Australia – name: 21 AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service des Pathologies du Sommeil (Département “R3S”), Paris, France – name: 3 Institute for Breathing and Sleep, Austin Hospital, Heidelberg, Australia – name: 7 Graduate School of Medicine, University of Wollongong, Wollongong, Australia – name: 12 Unité de Somnologie et Fonction Respiratoire, Hopital St Antoine, Paris, France – name: 14 Dept Otolaryngology, Head and Neck Surgery, Royal Perth Hospital, Perth, Australia – name: 13 Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France – name: 23 Nyxoah, S.A., Mont-Saint-Guibert, Belgium – name: 4 University of Melbourne, Parkville, Australia – name: 16 Service ORL Chirurgie de la Face et du Cou, Hôpital Tenon, AP-HP, Paris, Sorbonne Université, Paris, France – name: 22 AP-HP, Groupe Hospitalier Pitié-Salpêtrière Charles Foix, Service de Stomatologie et Chirurgie Maxillo-faciale, Paris, France – name: 5 Illawarra ENT Head and Neck Clinic, Wollongong, Australia – name: 11 Ludwig Engel Centre for Respiratory Research, The Westmead Institute for Medical Research, Westmead, Australia – name: 19 Dept of Respiratory and Sleep Medicine, University Hospital of Angers, Angers, France – name: 20 INSERM UMR 1063 “SOPAM”, University of Angers, Angers, France – name: 6 Wollongong Hospital, Illawarra Shoalhaven Local Health District (ISLHD), Wollongong, Australia – name: 9 Dept of Respiratory and Sleep Medicine, Westmead Hospital, Westmead, Australia – name: 18 Dept Otolaryngology, Head and Neck Surgery, University Hospital of Angers, Angers, France – name: 1 Centre for Sleep Science, School of Human Sciences, University of Western Australia, Perth, Australia |
| Author_xml | – sequence: 1 givenname: Peter R. orcidid: 0000-0002-4490-4138 surname: Eastwood fullname: Eastwood, Peter R. – sequence: 2 givenname: Maree surname: Barnes fullname: Barnes, Maree – sequence: 3 givenname: Stuart G. surname: MacKay fullname: MacKay, Stuart G. – sequence: 4 givenname: John R. surname: Wheatley fullname: Wheatley, John R. – sequence: 5 givenname: David R. surname: Hillman fullname: Hillman, David R. – sequence: 6 givenname: Xuân-Lan surname: Nguyên fullname: Nguyên, Xuân-Lan – sequence: 7 givenname: Richard surname: Lewis fullname: Lewis, Richard – sequence: 8 givenname: Matthew C. surname: Campbell fullname: Campbell, Matthew C. – sequence: 9 givenname: Boris surname: Pételle fullname: Pételle, Boris – sequence: 10 givenname: Jennifer H. surname: Walsh fullname: Walsh, Jennifer H. – sequence: 11 givenname: Andrew C. surname: Jones fullname: Jones, Andrew C. – sequence: 12 givenname: Carsten E. surname: Palme fullname: Palme, Carsten E. – sequence: 13 givenname: Alain surname: Bizon fullname: Bizon, Alain – sequence: 14 givenname: Nicole surname: Meslier fullname: Meslier, Nicole – sequence: 15 givenname: Chloé surname: Bertolus fullname: Bertolus, Chloé – sequence: 16 givenname: Kathleen J. surname: Maddison fullname: Maddison, Kathleen J. – sequence: 17 givenname: Laurent surname: Laccourreye fullname: Laccourreye, Laurent – sequence: 18 givenname: Guillaume surname: Raux fullname: Raux, Guillaume – sequence: 19 givenname: Katleen surname: Denoncin fullname: Denoncin, Katleen – sequence: 20 givenname: Valérie surname: Attali fullname: Attali, Valérie – sequence: 21 givenname: Frédéric surname: Gagnadoux fullname: Gagnadoux, Frédéric – sequence: 22 givenname: Sandrine H. surname: Launois fullname: Launois, Sandrine H. |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31601716$$D View this record in MEDLINE/PubMed https://hal.science/hal-02543235$$DView record in HAL |
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| Snippet | Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity
genioglossus muscle activation and decreased upper airway collapsibility.... Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity via genioglossus muscle activation and decreased upper airway... Background and aim Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity via genioglossus muscle activation and decreased upper... A new method of hypoglossal nerve stimulation to treat sleep apnoea does so bilaterally via an implanted neurostimulator activated externally. Its simplicity... |
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| Title | Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/31601716 https://www.proquest.com/docview/2305043208 https://hal.science/hal-02543235 https://pubmed.ncbi.nlm.nih.gov/PMC6949509 |
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