Faculty Collaboration Database

Multicenter study of a novel adjustable tongue-advancement device for obstructive sleep apnea. Otolaryngol Head Neck Surg 2010 Oct;143(4):585-90

Date

09/28/2010

Pubmed ID

20869572

DOI

10.1016/j.otohns.2010.06.902

Scopus ID

2-s2.0-77957283627 (requires institutional sign-in at Scopus site)   25 Citations

Abstract

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.

Author List

Woodson BT, Steward DL, Mickelson S, Huntley T, Goldberg A

Author

B Tucker Woodson MD Chief, Professor in the Otolaryngology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

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