J Dent Res87(9):882-887,2008
Hoekema, B. Stegenga,P.J. Wijkstra, J.H. van der Hoeven, A.F. Meinesz, and L.G.M. de Bont
Abstract
In clinical practice, oral appliances are used primarily for obstructive sleep apnea patients who do not respond to continuous positive airway pressure (CPAP) therapy. We hypothesized that an oral appliance is not inferior to CPAP in treating obstructive sleep apnea effectively. We randomly assigned 103 individuals to oral appliance or CPAP therapy. Polysomnography after 8-12 weeks indicated that treatment was effective for 39 of 51 persons using the oral appliance (76.5%) and 43 of 52 persons using CPAP (82.7%). For the difference in effectiveness , a 95% two sided confidence interval was calculated. Non-inferiority of oral appliance therapy was considered to be established when the lower boundary of this interval exceeded -25%. The lower boundary of the confidence interval was -21.7%, indicating that oral-appliance therapy was not inferior to CPAP for effective treatment of obstructive sleep apnea. However, a subgroup analysis revealed that oral-appliance therapy was less effective in individuals with severe disease (apnea-hypopnea index >30). Since these people could be at particular cardiovascular risk, primary oral-appliance therapy appears to be supported only for those with non-severe apnea.
Discussion
This randomized parallel trial showed that an oral appliance was not inferior to CPAP for effective treatment of obstructive sleep apnea. Non-inferiority of oral-appliance therapy was supported by a lack of significant differences in most polysomnographic and all neurobehavioral outcomes. However, CPAP was more effective in improving the apnea-hypopnea index and was superior to oral-appliance therapy for patients with severe disease. Since these findings suggest that oral-appliance therapy is indicated primarily for those with non severe obstructive sleep apnea, we recommend that it be considered, alongside CPAP therapy, as treatment for persons with mild to moderate disease. Among those with severe disease, oral-appliance therapy should be considered for individuals unwilling or unable to tolerate CPAP.
