PMID- 27010361 OWN - NLM STAT- MEDLINE DCOM- 20170727 LR - 20220331 IS - 1531-4995 (Electronic) IS - 0023-852X (Linking) VI - 126 IP - 11 DP - 2016 Nov TI - Targeted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea: Six-month results. PG - 2618-2623 LID - 10.1002/lary.25909 [doi] AB - 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 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. CI - (c) 2016 The American Laryngological, Rhinological and Otological Society, Inc. FAU - Friedman, Michael AU - Friedman M AD - Rush University Medical Center and Advanced Center for Specialty Care, Advocate Illinois Masonic Medical Center, Chicago, Illinois, U.S.A.. mfriedman@chicagoent.com. FAU - Jacobowitz, Ofer AU - Jacobowitz O AD - ENT and Allergy Associates, Orange Regional Medical Center, Middletown, New York, U.S.A. FAU - Hwang, Michelle S AU - Hwang MS AD - Rush University Medical Center and Advanced Center for Specialty Care, Advocate Illinois Masonic Medical Center, Chicago, Illinois, U.S.A. FAU - Bergler, Wolfgang AU - Bergler W AD - Head and Neck Department, St. Joseph Hospital, Bremen, Germany. FAU - Fietze, Ingo AU - Fietze I AD - Department of Cardiology, Center of Sleep Medicine, Charite-Universitatsmedizin Berlin, Berlin, Germany. FAU - Rombaux, Philippe AU - Rombaux P AD - Saint Luc University Clinics, Department of Oto-Rhino-Laryngology, Institute of Neurosciences, University of Louvain, Brussels, Belgium. FAU - Mwenge, Gimbada B AU - Mwenge GB AD - Saint Luc University Clinics, Department of Oto-Rhino-Laryngology, Institute of Neurosciences, University of Louvain, Brussels, Belgium. FAU - Yalamanchali, Sreeya AU - Yalamanchali S AD - Rush University Medical Center and Advanced Center for Specialty Care, Advocate Illinois Masonic Medical Center, Chicago, Illinois, U.S.A. FAU - Campana, John AU - Campana J AD - Colorado Head and Neck Specialists, Denver, Colorado, U.S.A. FAU - Maurer, Joachim T AU - Maurer JT AD - Mannheim University ENT Clinic, Mannheim, Germany. LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20160324 PL - United States TA - Laryngoscope JT - The Laryngoscope JID - 8607378 SB - IM MH - Adult MH - Aged MH - Electric Stimulation Therapy/*methods MH - Feasibility Studies MH - Female MH - Follow-Up Studies MH - Humans MH - *Hypoglossal Nerve MH - *Implantable Neurostimulators MH - Male MH - Middle Aged MH - Prospective Studies MH - Prosthesis Implantation/*methods MH - Severity of Illness Index MH - Sleep Apnea, Obstructive/physiopathology/*therapy MH - Treatment Outcome OTO - NOTNLM OT - Hypoglossal nerve stimulation OT - hypoglossal nerve OT - neurostimulation OT - obstructive sleep apnea OT - surgical treatment of obstructive sleep apnea EDAT- 2016/10/25 06:00 MHDA- 2017/07/28 06:00 CRDT- 2016/03/25 06:00 PHST- 2015/06/26 00:00 [received] PHST- 2015/11/23 00:00 [revised] PHST- 2016/01/11 00:00 [accepted] PHST- 2016/10/25 06:00 [pubmed] PHST- 2017/07/28 06:00 [medline] PHST- 2016/03/25 06:00 [entrez] AID - 10.1002/lary.25909 [doi] PST - ppublish SO - Laryngoscope. 2016 Nov;126(11):2618-2623. doi: 10.1002/lary.25909. Epub 2016 Mar 24.