title: Targeted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea: Six-month results.
abstract: 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.
  
  
  
  Open-label, prospective, multicenter, single-arm cohort study, conducted at seven centers in the U.S.A. and Europe.
  
  
  
  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.
  
  
  
  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 SpO2decrease > 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.
  
  
  
  This feasibility study suggests that THN therapy is likely to be safe and effective in selected patients.
  
  
  
  2b Laryngoscope, 126:2618-2623, 2016.
authors.affiliation: Rush University Medical Center and Advanced Center for Specialty Care, Advocate Illinois Masonic Medical Center, Chicago, Illinois, U.S.A.. mfriedman@chicagoent.com.
authors.forename: Michael
authors.initials: M
authors.lastname: Friedman
authors.affiliation: ENT and Allergy Associates, Orange Regional Medical Center, Middletown, New York, U.S.A.
authors.forename: Ofer
authors.initials: O
authors.lastname: Jacobowitz
authors.affiliation: Rush University Medical Center and Advanced Center for Specialty Care, Advocate Illinois Masonic Medical Center, Chicago, Illinois, U.S.A.
authors.forename: Michelle S
authors.initials: MS
authors.lastname: Hwang
authors.affiliation: Head and Neck Department, St. Joseph Hospital, Bremen, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Bergler
authors.affiliation: Department of Cardiology, Center of Sleep Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Ingo
authors.initials: I
authors.lastname: Fietze
authors.affiliation: Saint Luc University Clinics, Department of Oto-Rhino-Laryngology, Institute of Neurosciences, University of Louvain, Brussels, Belgium.
authors.forename: Philippe
authors.initials: P
authors.lastname: Rombaux
authors.affiliation: Saint Luc University Clinics, Department of Oto-Rhino-Laryngology, Institute of Neurosciences, University of Louvain, Brussels, Belgium.
authors.forename: Gimbada B
authors.initials: GB
authors.lastname: Mwenge
authors.affiliation: Rush University Medical Center and Advanced Center for Specialty Care, Advocate Illinois Masonic Medical Center, Chicago, Illinois, U.S.A.
authors.forename: Sreeya
authors.initials: S
authors.lastname: Yalamanchali
authors.affiliation: Colorado Head and Neck Specialists, Denver, Colorado, U.S.A.
authors.forename: John
authors.initials: J
authors.lastname: Campana
authors.affiliation: Mannheim University ENT Clinic, Mannheim, Germany.
authors.forename: Joachim T
authors.initials: JT
authors.lastname: Maurer
mesh_terms: D000328:Adult; D000368:Aged; D004599:Electric Stimulation Therapy / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007002:Hypoglossal Nerve; D058542:Implantable Neurostimulators; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019919:Prosthesis Implantation / Q000379:methods*; D012720:Severity of Illness Index; D020181:Sleep Apnea, Obstructive / Q000503:physiopathology / Q000628:therapy*; D016896:Treatment Outcome
keywords: Hypoglossal nerve stimulation; hypoglossal nerve; neurostimulation; obstructive sleep apnea; surgical treatment of obstructive sleep apnea