Multicenter study of a novel adjustable tongue-advancement device for obstructive sleep apnea

Otolaryngol Head Neck Surg. 2010 Oct;143(4):585-90. doi: 10.1016/j.otohns.2010.06.902.


Objective: The safety and clinical effect of a new surgical device for tongue suspension for obstructive sleep apnea (OSA) was assessed.

Study design: Multicenter phase 2 prospective case series.

Setting: Multicenter academic and private.

Subjects and 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.

Conclusion: 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.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Equipment Failure
  • Equipment and Supplies* / adverse effects
  • Female
  • Humans
  • Male
  • Mandible / surgery*
  • Middle Aged
  • Pain Measurement
  • Sleep Apnea, Obstructive / surgery*
  • Suture Anchors*
  • Tongue / surgery*
  • Treatment Outcome
  • Young Adult