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

Abstract

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 (> or =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.