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    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 treat... by B Tucker Woodson, Maria V Suurna, M Boyd Gillespie, Tod C Huntley, Melyssa Hancock, Angela Santos, Jeyakumar Subbaroyan, Fatima Makori, Grégoire Fesneau, Clemens Heiser, David T Kent

    Published 2024-12-01
    “…Secondary effectiveness endpoints include mean changes in quality-of-life assessments (daytime sleepiness and its effect on activities of daily living, OSA-specific quality of life, daytime sleepiness), levels of intermittent hypoxia, change in hypoxaemic burden and OSA severity.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. …”
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