• The Laryngoscope · Nov 2016

    Multicenter Study Clinical Trial

    Targeted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea: Six-month results.

    • Michael Friedman, Ofer Jacobowitz, Michelle S Hwang, Wolfgang Bergler, Ingo Fietze, Philippe Rombaux, Gimbada B Mwenge, Sreeya Yalamanchali, John Campana, and Joachim T Maurer.
    • Rush University Medical Center and Advanced Center for Specialty Care, Advocate Illinois Masonic Medical Center, Chicago, Illinois, U.S.A.. mfriedman@chicagoent.com.
    • Laryngoscope. 2016 Nov 1; 126 (11): 2618-2623.

    Objectives/HypothesisThis feasibility study was designed to show the preliminary safety and efficacy of targeted hypoglossal neurostimulation (THN), and to identify baseline predictors of successful therapy.Study DesignOpen-label, prospective, multicenter, single-arm cohort study, conducted at seven centers in the U.S.A. and Europe.MethodsForty-six participants with moderate to severe obstructive sleep apnea (OSA), failing or intolerant of continuous positive airway pressure, were implanted. Primary (Apnea-Hypopnea Index [AHI], Oxygen Desaturation Index [ODI]) and secondary (Arousal Index, Epworth Sleepiness Scale Index, Sleep Apnea Quality of Life Index) outcomes were measured at baseline and compared at 6 months. Data were analyzed to identify participant characteristics that would predict success with therapy.ResultsSixty-seven adverse events (AEs) were observed among 36 participants; most of the AEs were related to the implant procedure and resolved without sequelae; one device replacement was necessary. Forty-three participants showed significant (P < .01) decreases in both AHI and ODI at 6 months; 35% (15 of 43) met criteria for AHI responders and 40% (17 of 43) for ODI responders. Significant improvement was observed in all the secondary endpoints. Predictors-of-success selection criteria were identified as baseline AHI < 65/hr, baseline apnea index ≤ 30, baseline body mass index < 35, and <15 events/hr of SpO2 decrease > 10%. Seven participants met these criteria; 86% (6 of 7) were AHI responders and 86% (6 of 7) were ODI responders, indicating that THN therapy can be efficacious in a carefully selected population of OSA patients.ConclusionsThis feasibility study suggests that THN therapy is likely to be safe and effective in selected patients.Level Of Evidence2b Laryngoscope, 126:2618-2623, 2016.© 2016 The American Laryngological, Rhinological and Otological Society, Inc.

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