Am. J. Respir. Crit. Care Med., Volume 162, Number 1, July 2000, 246-251

A Randomized, Controlled Crossover Trial of Two Oral Appliances for Sleep Apnea Treatment

KONRAD E. BLOCH, ANGELO ISELI, JINNONG N. ZHANG, XIAOBIN XIE, VLADIMIR KAPLAN, PAUL W. STOECKLI, and ERICH W. RUSSI

Department of Internal Medicine, University Hospital of Zürich, and Department of Orthodontics and Dentofacial Orthopedics, University of Zürich, Zürich, Switzerland

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.

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