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.
Woodson
B Tucker
BT
Department of Otolaryngology, Medical College of Wisconsin, Milwaukee, WI, USA. bwoodson@mcw.edu
Steward
David L
DL
Mickelson
Samuel
S
Huntley
Tod
T
Goldberg
Andrew
A
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