OBJECTIVE: To evaluate the short-term safety and efficacy of palatal implants in patients with mild and moderate obstructive sleep apnea (OSA). STUDY DESIGN AND SETTING: A prospective, non-randomized study conducted at 5 clinical sites. Three polyester implants were placed in the soft palate under local anesthesia during a single-stage office procedure. Polysomnography was conducted at baseline and 90 days post-procedure. Subjective quality of life data were collected. RESULTS: Fifty-three patients were evaluated; the apnea hypopnea index (AHI) decreased from 25.0 +/- 13.9 to 22.0 +/- 14.8 events/hour (P = 0.05). The Epworth Sleepiness Scale (ESS) decreased from 11.0 +/- 5.1 to 6.9 +/- 4.5 (P < 0.001), and the snore score decreased from 7.9 +/- 2.1 to 4.0 +/- 3.0 (P < 0.001). No serious complications occurred during the study. CONCLUSION: Palatal implants can be an effective initial low morbidity treatment option for patients diagnosed with mild to moderate OSA.
OBJECTIVE: To evaluate the short-term safety and efficacy of palatal implants in patients with mild and moderate obstructive sleep apnea (OSA). STUDY DESIGN AND SETTING: A prospective, non-randomized study conducted at 5 clinical sites. Three polyester implants were placed in the soft palate under local anesthesia during a single-stage office procedure. Polysomnography was conducted at baseline and 90 days post-procedure. Subjective quality of life data were collected. RESULTS: Fifty-three patients were evaluated; the apnea hypopnea index (AHI) decreased from 25.0 +/- 13.9 to 22.0 +/- 14.8 events/hour (P = 0.05). The Epworth Sleepiness Scale (ESS) decreased from 11.0 +/- 5.1 to 6.9 +/- 4.5 (P < 0.001), and the snore score decreased from 7.9 +/- 2.1 to 4.0 +/- 3.0 (P < 0.001). No serious complications occurred during the study. CONCLUSION: Palatal implants can be an effective initial low morbidity treatment option for patients diagnosed with mild to moderate OSA.
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