Abstract
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.
Footnotes
This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.
Conflict of interest: Dr. Eastwood reports other from Nyxoah SA, during the conduct of the study; other from Oventus Pty Ltd, other from Zelda Therapeutics, outside the submitted work.
Conflict of interest: Dr. Barnes has nothing to disclose.
Conflict of interest: Dr. MacKay reports grants from NH&MRC, grants from Garnett- Passe RWF Conjoint Grant, outside the submitted work.
Conflict of interest: Dr. Wheatley reports grants from Nyxoah, during the conduct of the study.
Conflict of interest: Dr. Hillman reports other from Nyxoah SA, during the conduct of the study; other from Oventus Pty Ltd, other from Zelda Therapeutics, outside the submitted work.
Conflict of interest: Dr. Nguyên reports grants from Serenity Medical Services, during the conduct of the study.
Conflict of interest: Dr. Lewis reports personal fees from Nyxoah SA, during the conduct of the study.
Conflict of interest: Dr. Campbell reports personal fees from Nyxoah, outside the submitted work.
Conflict of interest: Dr. PETELLE reports grants from BLUESOM, other from NYXOAH, outside the submitted work.
Conflict of interest: Dr. Walsh reports other from Nyxoah SA, during the conduct of the study; other from Oventus Pty Ltd, other from Zelda Therapeutics, outside the submitted work.
Conflict of interest: Dr. Jones reports personal fees from Nyxoah, during the conduct of the study.
Conflict of interest: Dr. Palme reports personal fees from NYOXAH, during the conduct of the study.
Conflict of interest: Dr. bizon has nothing to disclose.
Conflict of interest: Dr. MESLIER has nothing to disclose.
Conflict of interest: Dr. Bertolus has nothing to disclose.
Conflict of interest: Dr. Maddison reports other from Nyxoah Pty Ltd, during the conduct of the study; other from Nyxoah Pty Ltd, other from Oventus Pty Ltd, other from Zelda Pty Ltd, grants from Institutional Grant - Sir Charles Gairdner Hospital, grants from Australian and New Zealand College of Anaesthetists research grant, outside the submitted work.
Conflict of interest: Dr. Laccourreye reports non-financial support from Medtronic France, non-financial support from Integra LifeSciences Services, outside the submitted work.
Conflict of interest: Dr. Raux has nothing to disclose.
Conflict of interest: Dr. Denoncin has nothing to disclose.
Conflict of interest: Dr. ATTALI reports personal fees from Nyxoah, during the conduct of the study; personal fees from Resmed, other from Imthera, outside the submitted work.
Conflict of interest: Dr. GAGNADOUX has nothing to disclose.
Conflict of interest: Dr. LAUNOIS reports other from Serenity Medical Services/Bioserenity, personal fees from CIDELEC, other from VITALAIRE, other from S2A Santé ASTEN LA POSTE, other from UCB Pharma, grants from RESMED, outside the submitted work.
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- Received July 4, 2019.
- Accepted September 21, 2019.
- Copyright ©ERS 2019