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

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.