Mandibular advancement appliances and obstructive sleep apnoea: a randomized clinical trial.

This randomized placebo-controlled cross-over trial assessed the effectiveness of a mandibular advancement appliance (MAA) in managing obstructive sleep apnoea (OSA). Twenty-one adults, with confirmed OSA, were provided with a maxillary placebo appliance and a MAA for 4-6 weeks each, in a randomized order. Questionnaires at baseline and after each appliance assessed bed-partners' reports of snoring severity (loudness and number of nights per week), and patients' daytime sleepiness (Epworth Sleepiness Score, ESS). The Apnoea Hypopnoea Index (AHI) and Oxygen Desaturation Index (ODI) were measured at baseline and with each appliance during single night sleep studies. Seventy-nine per cent of subjects wore their MAA for at least 4 hours at night. Sixty-eight per cent of subjects wore their MAA for 6-7 nights per week. Excessive salivation was the most commonly reported complication. One subject was unable to tolerate the MAA and withdrew from the study. Among the remaining 20 subjects, the MAA produced significantly lower AHI and ODI values than the placebo. However, although the reported frequency and loudness of snoring and the ESS values were lower with the MAA than the placebo, these differences were not statistically significant. When wearing the MAA, 35 per cent of the OSA subjects had a reduction in the pre-treatment ODI to 10 or less, while 33 per cent had an AHI of 10 or less. The MAA was less effective in the subjects with the most severe OSA (pre-treatment ODI > 50 and/or pre-treatment AHI > 50).

RCT Entities:   Population Interventions Outcomes