A randomized, controlled crossover trial of two oral appliances for sleep apnea treatment.

Abstract

Our purpose was to compare the effectiveness and side effects of a novel, single-piece mandibular advancement device (OSA-Monobloc) for sleep apnea therapy with those of a two-piece appliance with lateral Herbst attachments (OSA-Herbst) as used in previous studies. An OSA-Monobloc and an OSA-Herbst with equal protrusion were fitted in 24 obstructive sleep apnea patients unable to use continuous positive airway pressure (CPAP) therapy. After an adaptation period of 156 +/- 14 d (mean +/- SE), patients used the OSA-Monobloc, the OSA-Herbst, and no appliance in random order, using each appliance for 1 wk. Symptom scores were recorded and sleep studies were done at the end of each week. Several symptom scores were significantly improved with both appliances, but to a greater degree with the OSA-Monobloc. Epworth Sleepiness Scale scores were 8.8 +/- 0.7 with the OSA-Herbst, and 8.6 +/- 0.8 with the OSA-Monobloc devices, and 13.1 +/- 0.9 without therapy (p < 0.05 versus both appliances). The apnea/hypopnea index was 8.7 +/- 1.5/h with the OSA-Herbst and 7.9 +/- 1.6/h with the OSA-Monobloc device, and 22.6 +/- 3.1/h without therapy (p < 0.05 versus both appliances). Side effects were mild and of equal prevalence with both appliances. Fifteen patients preferred the OSA-Monobloc, eight patients had no preference, and one patient preferred the OSA-Herbst device (p < 0.008 versus OSA-Monobloc). We conclude that both the OSA-Herbst and the OSA-Monobloc are effective therapeutic devices for sleep apnea. The OSA-Monobloc relieved symptoms to a greater extent than the OSA-Herbst, and was preferred by the majority of patients on the basis of its simple application.

• Authors: K E Bloch, A Iseli, J N Zhang, X Xie, V Kaplan, P W Stoeckli, E W Russi
• Journal: American journal of respiratory and critical care medicine (Am J Respir Crit Care Med) Vol. 162 Issue 1 Pg. 246-51 (Jul 2000) ISSN: 1073-449X [Print] United States
• PMID: 10903249 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Topics

• Cross-Over Studies
• Equipment Design
• Follow-Up Studies
• Humans
• Middle Aged
• Orthodontic Appliances, Removable
• Prospective Studies
• Sleep Apnea, Obstructive (therapy)