Palate implants for obstructive sleep apnea: Multi-institution, randomized, placebo-controlled study

OBJECTIVE: To determine efficacy of Pillar palate implants for mild to moderate obstructive sleep apnea (OSA) syndrome. DESIGN: Multi-institution, randomized, double-blind, placebo-controlled study. METHODS: One hundred patients with mild to moderate OSA and suspected retropalatal obstruction were randomly assigned treatment with three palatal implants or sham placebo. RESULTS: Final apnea-hypopnea index (AHI) increased for both groups at 3 months, correlating with increased percentage of supine sleep but was less in the implant group (P = 0.05). A clinically meaningful reduction in AHI ( >= 50% reduction to <20) was more common in the implant group (26% vs 10%, P = 0.05). Significant differences were noted for changes in lowest oxyhemoglobin saturation (P = 0.007) and Functional Outcomes of Sleep Questionnaire (P = 0.05). Improvement in Epworth Sleepiness Score did not differ from that of sham (P = 0.62). Partial implant extrusion occurred in two patients (4%). CONCLUSION: Palate implants for mild to moderate obstructive sleep apnea demonstrated efficacy over placebo for several important outcomes measures with minimal morbidity, but overall effectiveness remains limited. Further study is needed. (C) 2008 American Academy of Otolaryngology-Flead and Neck Surgery Foundation. All rights reserved.