Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea in adults: a protocol for a pivotal, multicentre, open-label, single-arm study.

introductionObstructive sleep apnoea (OSA) is characterised by blood oxygen desaturations and sleep disruptions manifesting undesirable consequences. Existing treatments including oral appliances, positive airway pressure (PAP) therapy and surgically altering the anatomy of the pharynx have drawbacks including poor long-term adherence or often involving irreversible, invasive procedures. Bilateral hypoglossal nerve stimulation (HNS METHODS AND ANALYSIS: This is a pivotal, multicentre, prospective, single-arm study of HNS ETHICS AND DISSEMINATION: The Food and Drug Administration, Advarra Institutional Review Board (IRB), University of Tennessee HSC IRB, University of Pennsylvania IRB, Weill Cornell Medicine IRB, Medical College of Wisconsin/Froedert Hospital, Human Research Protections Programme Vanderbilt University, St. Vincent's Hospital Melbourne Human Research Ethics Committee, Ethisch Comite Universitair Ziekenhuis Antwerpen and Technische Universitat Munchen reviewed and approved this protocol. Study results will be disseminated through journal publications, updates to ClinicalTrials.gov and the Nyxoah website, and presentations at meetings and conferences. TRIAL REGISTRATION NUMBER: NCT03868618.