Faculty Collaboration Database

Palate implants for obstructive sleep apnea: multi-institution, randomized, placebo-controlled study. Otolaryngol Head Neck Surg 2008 Oct;139(4):506-10

Date

10/17/2008

Pubmed ID

18922335

DOI

10.1016/j.otohns.2008.07.021

Scopus ID

2-s2.0-52149103190 (requires institutional sign-in at Scopus site)   53 Citations

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.

Author List

Steward DL, Huntley TC, Woodson BT, Surdulescu V

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

Double-Blind Method
Female
Humans
Male
Middle Aged
Prostheses and Implants
Quality of Life
Sleep Apnea, Obstructive