Abstract

OBJECTIVE: To investigate the effects of the Klearway(TM) appliance on the upper airway in patients with obstructive sleep apnea (OSA) in the supine position. METHODS: Sixteen subjects (12 males and 4 females) were recruited on the basis of baseline polysomnography with a documented Apnea and Hypopnea Index (AHI) >15 per hour. A second overnight sleep study was performed for each subject with the appliance in place. Baseline supine cephalometry was performed for each subject before the initial insertion of the appliance, and follow-up supine cephalometry was undertaken with the appliance in place. RESULTS: The polysomnographic variables improved significantly, and the mean changes in overbite and overjet were 5.15 mm and 6.26 mm after insertion of the Klearway(TM) appliance. The supine sagittal cross-sectional areas of the pharynx and the tongue significantly increased, while the linear distance from the hyoid position to the mandibular plane or the RGN-C3 line significantly decreased after insertion of the appliance. The ratio of the vertical pharyngeal length to the sagittal cross-sectional area of nasopharynx or tongue decreased significantly. When the subjects were evaluated on the basis of the after-insertion AHI, the group with good response (n = 11) was found to be significantly younger than the group with the poor response (n = 5). Similarly, the good responders revealed less prominent chins, larger tongue heights, and an increase in hypopharyngeal sagittal cross-sectional area after insertion of the appliance. There was a significant correlation between the improvement in AHI (%) and the supine middle airway space (r = -0.52, p < 0.05). CONCLUSION: The mechanical effect of the Klearway(TM) appliance on the upper airway and the stabilization of jaw posture may be important determinants of the efficacy of the appliance.

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