title: Multicenter study of a novel adjustable tongue-advancement device for obstructive sleep apnea.
abstract: OBJECTIVE
  The safety and clinical effect of a new surgical device for tongue suspension for obstructive sleep apnea (OSA) was assessed.
  
  
  METHODS
  Multicenter phase 2 prospective case series.
  
  
  METHODS
  Multicenter academic and private.
  
  
  METHODS
  Surgically naïve patients with moderate-to-severe OSA and tongue base obstruction (body mass index < 32, apnea/hypopnea index [AHI] 15-60) underwent surgical insertion of a midline tissue anchor into the posterior tongue and connected to an adjustable mandibular bone anchor with a flexible tether. Outcomes included changes in AHI, sleepiness (Epworth Sleepiness Scale), sleep-related quality-of-life (Functional Outcomes of Sleep Questionnaire), snoring, swallowing, speech, and pain (0-10 visual analog scale).
  
  
  RESULTS
  After the implant, 42 patients (mean age 50 years, body mass index 28) noted improvement at six months for AHI (mean [SD]: 35.5 [20.4] to 27.3 [18.8]), Epworth Sleepiness Scale (11.5 [3.9] to 7.8 [4.7]), and Functional Outcomes of Sleep Questionnaire (15.5 [2.6] to 17.5 [2.6], all P < 0.01). Snoring VAS scores improved (7.3 [2.1] to 4.7 [2.9], P < 0.01). Postimplant pain scores were mild to moderate (4.4) at day one and resolved by day five. Post-titration pain scores were mild (< 2). Device-related adverse events included wound infection (7%) and edema or seroma (5%), which resolved. However, in 31 percent of patients, asymptomatic tissue anchor barb fractures were observed radiographically.
  
  
  CONCLUSIONS
  The tissue anchor failure rate of the tested device precludes its clinical use; however, the study results support that a titratable, tongue-suspension device with low direct surgical morbidity in patients with moderate-to-severe sleep apnea significantly improves multiple measures of sleep apnea. Further investigation is warranted.
authors.affiliation: Department of Otolaryngology, Medical College of Wisconsin, Milwaukee, WI, USA. bwoodson@mcw.edu
authors.forename: B Tucker
authors.initials: BT
authors.lastname: Woodson
authors.forename: David L
authors.initials: DL
authors.lastname: Steward
authors.forename: Samuel
authors.initials: S
authors.lastname: Mickelson
authors.forename: Tod
authors.initials: T
authors.lastname: Huntley
authors.forename: Andrew
authors.initials: A
authors.lastname: Goldberg
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004868:Equipment Failure; D004864:Equipment and Supplies / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008334:Mandible / Q000601:surgery*; D008875:Middle Aged; D010147:Pain Measurement; D020181:Sleep Apnea, Obstructive / Q000601:surgery*; D053441:Suture Anchors; D014059:Tongue / Q000601:surgery*; D016896:Treatment Outcome; D055815:Young Adult