Targeted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea: Six‐month results. (24th March 2016)

• Record Type: Journal Article
• Authors: Friedman, Michael; Jacobowitz, Ofer; Hwang, Michelle S.; Bergler, Wolfgang; Fietze, Ingo; Rombaux, Philippe; Mwenge, Gimbada B.; Yalamanchali, Sreeya; Campana, John; Maurer, Joachim T.
• Is Part Of: Laryngoscope. Volume 126:Number 11(2016:Nov.)
• Page Start: 2618
• Page End: 2623
• Publication Date: 2016-03-24
• Subjects: Hypoglossal nerve stimulation -- obstructive sleep apnea -- neurostimulation -- hypoglossal nerve -- surgical treatment of obstructive sleep apnea; Otolaryngology -- Periodicals; 617.51005
• DOI: 10.1002/lary.25909
• Languages: English
• ISSNs: 0023-852X

Abstract

Abstract : Objectives/Hypothesis: This 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 Design: Open‐label, prospective, multicenter, single‐arm cohort study, conducted at seven centers in the U.S.A. and Europe. Methods: Forty‐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. Results: Sixty‐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. Conclusions: This feasibility study suggests that THN therapy is likely to be safe and effective in selected patients. Level of Evidence: 2b Laryngoscope, 126:2618–2623, 2016